Zhejiang Luyao Electronics Technology Co., Ltd.

Manufacturer and brand owner in Wenzhou, Zhejiang, China. 5 device types, 1 product catalogued, 1 clearance.

Registry build 21.09.26

Zhejiang Luyao Electronics Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Orthosis, Thoracic, Band Or Belt, Pelvic Support and 3 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2016.

5device types registered with the FDA
1product
1510(k) clearance
1recall

Registration

FDA registration record for Zhejiang Luyao Electronics Technology Co., Ltd.
Registered name ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO.,LTD
Status Registered
Registration expires 2026
Registration number 3009942828
FEI number 3009942828
DUNS 528189371
Establishment type Manufacturer, Exporter

Chinese Registration

Chinese company register details for Zhejiang Luyao Electronics Technology Co., Ltd.
Chinese legal name 浙江璐瑶电子科技有限公司
Source customs registration record

Location

Address of Zhejiang Luyao Electronics Technology Co., Ltd.
City Wenzhou
Province Zhejiang
Address Wei 1st Road,Mechanical Park,Wanquan Light Industrial Base
Postal code 325409
Country China

What It Makes

Device types Zhejiang Luyao Electronics Technology Co., Ltd. is registered to make
Device type Class Listed under the names Listed since Chinese makers
Band Or Belt, Pelvic Support Class 1 Support belt 2018 54
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua Class N Face mask, Disposable face mask, Protective mask, LY-D900, LY-D901, LY-D902, LY-D903, LY-D904, LY-D905, LY-D906, LY-D907, LY-D908, LY-D909, LY-N900, LY-N901, LY-N902, LY-N903, LY-N904, LY-N905, LY-N906, LY-N907, LY-N908, LY-N909 2020 182
Massager, Powered Inflatable Tube Class 2 Air compression knee massager models LY-670E, Air Compression Leg Massager with models LY-670A, LY-670B, LY-670C, LY-670D,LY-670E,, Air compression calf massager models LY-670A, Air Compression Leg Massager (Real Relief Leg Compression) models SR-160HJ 2023 37
Massager, Therapeutic, Electric Class 1 Knee Massager with Heat: NK-KP03, Heat and Cold Therapy Device, Massage Gun,head Massager,hand Massager,knee Massager,leg Massager, Facial Roller KIT, Mini massager,Eye massager, Foot spa massager, Foot massager, Neck and shoulder massager, Massage cushion, Massage hammer, Massage pillow and 8 more 2016 437
Orthosis, Thoracic Class 1 Posture Corrector Brace 2021 30

Own-Brand Listings

Devices catalogued by Zhejiang Luyao Electronics Technology Co., Ltd.
Product Code Catalogue numbers
Luyao IPR 1

Clearances

510(k) clearances naming Zhejiang Luyao Electronics Technology Co., Ltd. or its listings
Clearance Decision date Product code Route Held by
K222949 2022-12-22 IRP Traditional This company

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls naming Zhejiang Luyao Electronics Technology Co., Ltd.
Initiated FDA class Root cause Reason Quantity
2025-01-17 Class II Error in labeling Regulatory documentation error and misleading color packaging claim. 3705 US

From the Company

Published by the company on its own website, not by the FDA.

Information published by Zhejiang Luyao Electronics Technology Co., Ltd.
Founded 2001
Employees 600
Factory area 30000 m²
Main products Massage sticks, Foot baths, Massage cushions, Foot massage machines
Certifications ISO9001:2008, FDA, CE, ROHS, UL, ETL, FCC
Export markets Global

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Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

The manufacturer named here can complete this record.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

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2,581device types they are registered for
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