Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006891384

FEI Number

3006891384

Entity Name

JIANGSU ALPHAY MEDICAL DEVICE CO., LTD.

City/State/Country

Nantong Jiangsu, CN

Establishment Address

No. 95, Zhenxing Road , Economical & Development Zone, Nantong Jiangsu 226009, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

JIANGSU ALPHAY INTERNATIONAL TRADE CO., LTD. (Owner Number: 10023966)

Owner / Operator Contact Address

No. 95, Zhenxing Road, Economical & Development Zone, Nantong, CN-JS 226009, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Lumbar Traction Device; CERVICAL CARE DEVICE lower back stretching massager Leg massager Lumbar massager Neck massager Calf care device Lumbar massage belt Knee massager Air-traction Belt ; back support belt Care Max, Knee Care Device Lumbar Lift Back Stretcher Air-traction Belt Neck Air-traction Device Neck Support Neck brace Neck-Traction Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2017-02-12
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2015-06-15
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2012-11-21
ILZ	Accessories, Traction	Physical Medicine	Class 1	890.5925	2007-12-24
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2007-12-24
HST	Apparatus, Traction, Non-Powered	Orthopedic	Class 1	888.5850	2013-08-19

Official Correspondent

Xu Gu

US Agent Details

James H Liao Email: james@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

JIANGSU ALPHAY INTERNATIONAL TRADE CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K881862	Thermo Body Wrap Systems, Inc.	THERMO-BODY-WRAP SYSTEM	1988-10-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101

Similar Registrations

Registration Number	Establishment Name	Location
3016460723	ZHEJIANG AOLIN INDUSTRY & TRADE CO., LTD.	Lishui Zhejiang, CN
3032903908	TECHDERM LLC	Palm Beach Gardens, FL, US
3030407739	CL MEDIX INC	Chantilly, VA, US
3009079475	Aerotel Ltd.	Holon Central, IL
3025350087	LENYO WORLD LTD	Budapest, HU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006891384. Last updated year: 2026. Please use registration number 3006891384 when referencing this establishment in official correspondence.