Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015339737

FEI Number

3015339737

Entity Name

HEALTH PLUS (SHANGHAI) INTERNATIONAL CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

Room 1-X3, Building 6, 4299 Jindu Road, Minhang district, Shanghai 201108, CN

Establishment Type(s)

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

Owner / Operator

Health Plus (Shanghai) International Co., LTD (Owner Number: 10059733)

Owner / Operator Contact Address

Room 1-X3, Building 6, 4299 Jindu Road, Minhang district, Shanghai, CN-SH 201108, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Hot Cold Comfort Belt (with the pack) Hot Cold Pack Comfort Belt

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2019-04-05
ILD	Adaptor, Dressing	Physical Medicine	Class 1	890.5050	2024-09-13
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2024-11-08
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2023-02-16

Official Correspondent

Lijun Yin

US Agent Details

Tom Welch Email: tom.welch@stone-breaker.com Phone: (415) 6800374

Related Public Records

Same Entity

Health Plus (Shanghai) International 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015339737. Last updated year: 2026. Please use registration number 3015339737 when referencing this establishment in official correspondence.