Data / Medical devices / China / Zhejiang Luyao Electronics Technology Co.,ltd

Zhejiang Luyao Electronics Technology Co.,ltd: FDA-registered device maker in Wenzhou Zhejiang, China, 1 510(k) clearance

Name: Zhejiang Luyao Electronics Technology Co.,ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zhejiang Luyao Electronics Technology Co.,ltd is registered with the FDA (registration 3009942828) in Wenzhou Zhejiang, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Zhejiang Luyao Electronics Technology Co.,ltd

FDA registration number: 3009942828
Address: Wei 1st Road,Mechanical Park,Wanquan Light Industrial Base Pingyang County, Wenzhou City, Zhejiang Province, China, Wenzhou Zhejiang, China, 325409
Owner or operator: ZHEJIANG LUYAO ELECTRONICS TECHNOLOGY CO.,LTD (10053050)
Roles: Exporter to the US, Manufacturer
First device listed: October 26, 2016
Registered through: 2026
Brand names listed: Air Compression Leg Massager (Real Relief Leg Compression) models SR-160HJ, 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 knee massager models LY-670E, Back Massager, COLLAPSIBLE PEDI SPA, DELUXE PEDI SPA, FACIAL ROLLER KIT and more

Devices it lists

Device	Product code	Class	Role	Source
Band Or Belt, Pelvic Support	ISR	1	Manufacturer	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Exporter to the US, Manufacturer	accessdata.fda.gov
Massager, Powered Inflatable Tube	IRP	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Orthosis, Thoracic	IPT	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 22, 2022	K222949	Air Compression Leg Massager (Model: LY-670D)	IRP	Substantially Equivalent	Zhejiang Luyao Electronics Technology Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 17, 2025	97333	Class II	Ongoing	Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Massager is indicated for the	Regulatory documentation error and misleading color packaging claim.	accessdata.fda.gov

Compare with other makers

Updated August 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.