Your Regulatory Checklist for Importing 3D Massage Chairs to the US

ETL certification for 3D massage chairs, issued by Intertek under certificate number 5030347.

Short answer: a 3D massage chair entering the United States is cleared by two different documents doing two different jobs. An FDA establishment registration filed under 21 CFR 807.39 - registration number 3017618816 for Ningbo Zhouqi Health Technology Co., Ltd. (ZHOUQI) - identifies a manufacturing facility in the FDA registration system. An ETL listing - certificate 5030347 issued by Intertek against UL 1647:2015 Ed.6 - certifies the product itself against the applicable US and Canadian electrical safety standard. Neither document replaces the other, and an import file containing only one of them is incomplete.

Why a 3D Massage Chair Needs Two Compliance Tracks, Not One

A 3D massage chair is a motorized furniture product. It plugs into a wall outlet, carries a roller mechanism that moves on a track, and is sold into homes, showrooms, hotels and wellness venues. That combination puts it inside two regulatory systems at the same time - one that looks at the facility, and one that looks at the product.

Track one is facility-level. An establishment registration records who makes the product and where. It is filed under a specific regulation and it carries a registration number, a scope and a validity period. It answers the question "is this a registered manufacturing establishment?"

Track two is product-level. A safety listing such as ETL records that a defined product family was evaluated against a defined standard by an accredited third party. It answers the question "has this appliance been tested and listed as safe for this market?"

The confusion between the two is structural, not accidental. Both are often described loosely as "certification," both carry a number, and both are often shown side by side in a supplier's document folder. The practical result is that many importers ask a single question - "do you have FDA?" - and never ask the follow-up that actually protects them: what exactly is registered, what exactly is listed, and under which standard revision?

Industry Background: A Large Market With Rising Documentation Expectations

North America is not a marginal destination for this category. North America dominated the massage equipment market in 2024 with a revenue share of 36.9%, according to Grand View Research. Within that market, massage chairs and sofas held the largest product share at 39.5% in 2024, from the same source.

The category is also still expanding. Business Research Insights projects the global massage chair market to grow from USD 4.28 billion in 2026 to USD 8.78 billion by 2035 at a CAGR of 8.3%. More volume into a mature, heavily regulated retail channel usually means more scrutiny of paperwork, not less - particularly for products with motors, heating elements and power supplies.

For an importer, the practical consequence is simple: compliance documents are no longer a formality attached to a purchase order. They are part of the product definition, and they must be verified before production, not after a container has sailed.

Track 1 in Detail: FDA Establishment Registration Under 21 CFR 807.39

FDA establishment registration filed under 21 CFR 807.39, registration number 3017618816.

The registration held by ZHOUQI records the following details, and every one of them should be read separately rather than as a single "yes":

• Registration number: 3017618816
• Regulation cited: 21 CFR 807.39
• Scope: massage chairs
• Market: United States
• Body named on the certificate: Shenzhen CTB Testing Technology Co., Ltd.
• Issue date: 16 December 2024
• Validity shown: through 31 December 2026

Read carefully, this document does two things. It confirms that a facility is registered, and it gives you a number you can quote in an import file. It does not test the chair, it does not evaluate the electrical assembly, and it is not a product approval. A registration number should never be presented to a buyer as proof that a massage chair is safe to plug in.

Track 2 in Detail: ETL Certification Under UL 1647:2015

The second track is the one that actually covers the product. ZHOUQI holds ETL certification 5030347, issued by Intertek for the US and Canadian markets.

• Certificate number: 5030347
• Certification body: Intertek
• Mark: ETL
• Markets covered: United States and Canada
• Scope: massage chairs
• Standard: UL 1647:2015 Ed.6 + R:30Jul2020; CSA C22.2#68:2018 Ed.8+U1
• Issue date: 13 January 2025

The 3D Massage Chair range associated with this listing covers models 5200, 5900, 5910, 3100, 6710, 8700, 3600, 3212, 6520, 5100, 6530, 3104, 3109, 6750, 6720 and 6721. When you review a listing, the model range matters as much as the certificate number: a listing that names your exact model, and the standard revision it was evaluated against, is the document a US buyer or retailer will ask to see.

The standard reference itself deserves attention. UL 1647:2015 Ed.6 is shown together with a revision dated 30 July 2020, and the Canadian counterpart is CSA C22.2#68:2018 Ed.8 with update 1. Standards are revised over time, so the revision string on the certificate tells you the vintage of the evaluation - not just that an evaluation happened.

Step-by-Step: The US Import Checklist

Step 1 - Fix the product classification first

Decide what the product actually is before collecting paper: a motorized massage chair with a 3D roller mechanism, sold as furniture for home, commercial or institutional use. Every document you request afterwards should use language that matches that classification. Mismatches between the product description on a certificate and the product on the bill of lading are a common cause of delay.

Step 2 - Pull the establishment registration and read four fields

Request the registration document itself and read the number (3017618816), the regulation cited (21 CFR 807.39), the scope (massage chairs) and the validity period (issued 16 December 2024, shown valid through 31 December 2026). Confirm the document is legible, complete and consistent with the manufacturer name on your contract.

Step 3 - Pull the ETL listing and read the standard revision

Request ETL certificate 5030347 and check that Intertek is named as the certification body, that the markets are the United States and Canada, that the scope is massage chairs, and that the model you are buying appears in the listed range. Confirm the exact standard string: UL 1647:2015 Ed.6 + R:30Jul2020 with CSA C22.2#68:2018 Ed.8+U1.

Step 4 - Match the electrical configuration to the US supply

Electrical parameters should line up with the destination market before the order is placed. The ZHOUQI 3D Massage Chair specification lists a power input of 110V-240V, 50/60Hz, a rated power of 150W and a 15-minute auto timer. The chair measures 1590(L) x 800(W) x 1160(H) mm upright and 1895(L) x 800(W) x 940(H) mm reclined, with a box dimension of 1950(L) x 810(W) x 880(H) mm and a net/gross weight of 111/135 kg. Materials are iron, foam, leather and ABS plastic.

Step 5 - Separate global certificates from US-facing ones

ISO 9001:2015 certificate 02424Q32202999R1S, held alongside the CB, CE, ETL and FDA documents.

ZHOUQI also holds CB certification NO127967 from Nemko, CE certification ENB2311240186E00401C from EMTEK, ISO 9001:2015 certificate 02424Q32202999R1S and ISO 13485:2016 certificate 133640 from NQA. None of these are US import documents on their own. They are useful evidence of process discipline and of readiness for other markets, and they should be filed as such - clearly labelled, never presented as a substitute for the ETL listing.

Step 6 - Audit documentation control, not just the certificate folder

Outgoing quality control at the factory gate - the point where production records and certificates have to agree.

A certificate is only as strong as the factory system that keeps it valid. Ask how the manufacturer controls the link between the listed model range and what is actually built: who signs off on a component change, how production changes are routed back to the certification body, and how the QC record is stored. ZHOUQI operates a 100% QC test regime, and acceptance includes a pre-shipment test plus third-party inspection by SGS. Those two mechanisms are the operational side of the same promise the ETL listing makes on paper.

Step 7 - Write compliance into the commercial terms

Compliance obligations should appear in the purchase contract, not only in an email thread. Confirm the commercial package before signing: MOQ of 1*40HQ container, delivery terms FOB Ningbo, acceptance criteria covering pre-shipment test and third-party inspection by SGS, and payment terms of 30% T/T deposit in advance with the balance of 70% T/T before shipment.

Step 8 - Build one version-controlled import file

Production workshop: the physical counterpart of every document in the import file.

Keep the registration, the ETL listing, the QC records and the acceptance report in one file with dates. When a standard revision changes or a validity date approaches, you will know immediately which documents need refreshing and which order they affect.

What the Other Certificates Prove - and What They Do Not

The fastest way to remove confusion from a document pack is to read each certificate against the question it was designed to answer. The table below sets out the documents ZHOUQI holds, their scope and their limits.

Read as a set, the documents are complementary. Read as a pile, they invite mistakes - which is why the checklist orders them by function rather than by date.

Use Cases: Who Runs This Checklist and When

Different buyer profiles meet the same two-track requirement at different moments in their buying cycle.

• US e-commerce sellers and DTC brands need the ETL listing before listing a product, because marketplace compliance teams ask for the standard revision, not just the certificate number.
• Furniture and home-appliance malls, and 4S showrooms usually ask for both documents at the point of purchase-order approval, because the product becomes part of a showroom floor with a public safety obligation.
• Hotels, resorts and wellness venues treat the listing as part of their own liability review, since the chair is used by guests with no supervision.
• Senior-care and healthcare institutions often evaluate ISO 13485 alongside the product listing, because institutional procurement reads process certificates as part of supplier qualification.

ZHOUQI's 3D massage chairs are used across home furniture, cultural-tourism and hospitality, wellness and beauty, healthcare, corporate office, real estate and property management, transportation, retail and entertainment, public service venues, automobile 4S showrooms, bank VIP lounges and university faculty lounges.

Delivery data from two markets illustrates how the model range performs at volume. A Vietnam-based channel has taken 70,000 pieces over four years, and a US-based channel has taken 20,000 pieces over three years. Both programmes are reported as improving, with the recurring note that the design is popular and the quality-to-price balance is favourable - which is exactly the combination that the ETL listing and the establishment registration have to keep supporting as volume grows.

Buyer Acceptance and Commercial Terms

Compliance and commercial terms meet at the acceptance stage. For this product, acceptance covers a pre-shipment test and third-party inspection by SGS. Production capacity is 16,000 units per month, with a lead time of 30 to 45 days and an MOQ of 1*40HQ container. After-sales support runs for one year, backed by installation videos and a maintenance manual.

OEM and ODM services are available, which matters because a US-bound configuration often differs from a domestic one. ODM services cover colour, logo, OEM file, pillow and backrest design, UI and language customization. Any customization that touches the electrical assembly, the control interface or the upholstery structure should be reviewed against the listed scope before production starts - that review is the bridge between an engineering decision and a compliance decision.

Frequently Asked Questions

1. Does FDA registration number 3017618816 mean the 3D massage chair is FDA approved?

No. Registration 3017618816 was filed under 21 CFR 807.39 and is an establishment registration covering massage chairs, with the United States as the listed market. The certificate is dated 16 December 2024 and shows validity through 31 December 2026. It identifies a registered facility; it does not test or approve the chair as a product. Electrical safety for the US and Canadian markets is covered separately by Intertek ETL certificate 5030347, evaluated against UL 1647:2015 Ed.6 + R:30Jul2020 and CSA C22.2#68:2018 Ed.8+U1. Importers should always hold both documents, because they answer two different questions.

2. Can I source an OEM mechanical 3D massage chair with custom upholstery?

Yes. ZHOUQI provides both OEM and ODM production services, and ODM covers colour, logo, OEM file, pillow and backrest design, UI and language customization. Custom upholstery sits inside that scope of design customization. The ETL listing 5030347 applies to the massage chair range that includes models 5200, 5900, 5910, 3100, 6710, 8700, 3600, 3212, 6520, 5100, 6530, 3104, 3109, 6750, 6720 and 6721, so any customization that changes the electrical assembly or control interface should be checked against the listed scope before mass production.

3. What are the minimum order quantity, delivery and payment terms?

The MOQ is 1*40HQ container. Delivery terms are FOB Ningbo. Payment terms are 30% T/T in advance as a deposit, with the remaining 70% T/T payable before shipment.

4. How is quality accepted before shipment?

Acceptance combines a pre-shipment test with third-party inspection by SGS, on top of a 100% QC test regime in production. The inspection report forms part of the import file alongside the establishment registration and the ETL listing.

5. What lead time and monthly capacity should an importer plan around?

Lead time is 30 to 45 days, with a monthly capacity of 16,000 units. After-sales support is a one-year warranty, supported by installation videos and a maintenance manual. Importers planning a first US programme can review the full 3D Massage Chair range and specification package before committing to a production slot.

Conclusion

Importing a 3D massage chair into the United States is a two-document exercise. The FDA establishment registration - number 3017618816 under 21 CFR 807.39 - registers the facility. The Intertek ETL certificate 5030347, evaluated against UL 1647:2015 Ed.6 + R:30Jul2020 and CSA C22.2#68:2018 Ed.8+U1, covers the product for the US and Canadian markets. The CB, CE, ISO 9001 and ISO 13485 certificates are supporting evidence of process discipline, not substitutes for either.

The checklist itself is short: confirm the classification, read the registration fields, read the listing's standard revision, match the electrical configuration, separate global certificates from US-facing ones, audit documentation control, write compliance into the commercial terms, and keep one dated file. Done in that order, the paperwork stops being a last-minute scramble and becomes what it should have been from the start - part of the product specification.

A ZHOUQI 3D massage chair in a home setting - the end point of a complete US import file.