Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014065673

FEI Number

3014065673

Entity Name

SHANGHAI GUANYIN ICE PACK CO.,LTD

City/State/Country

Shanghai, CN

Establishment Address

Floor 5th., No.16 Building, No.2433 Songzheng RD., Songjiang District, Shanghai 201600, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shanghai Guanyin Ice Pack Co.,Ltd (Owner Number: 10058706)

Owner / Operator Contact Address

Floor 5th., No.16 Building, No.2433 Songzheng RD., Songjiang District, Shanghai, CN-SH 201600, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ice pack ,Super ice pack ,Hot cold pack ,Hand warmer, Instant ice pack,Instant hot pack,hot pack Ice pad,Cool gel mat,Cool gel eye mask,Ice box,Gel facial mask,Cool scarf,ice towel,pet cool mat Cool Cap,Cool pillow,Bottle Cooler,cooling vest,Gel insole Head therapy products,Heat pad,Waist therapy productst,Cold pack aqua pearls,Ice bead products Gel facial mask,Cool scarf,ice towel,pet cool mat,Cool Cap Waist therapy productst,Cold pack aqua pearls,Ice bead products Cool pillow,Bottle Cooler,cooling vest,Gel insole,Head therapy products,Heat pad Instant hot pack,hot pack,Ice pad,Cool gel mat, Cool gel eye mask, Ice box Ice pack,Super ice pack,Hot cold pack,Hand warmer, Instant ice pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2018-10-22
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2018-10-22

Official Correspondent

Jack Guo

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shanghai Guanyin Ice Pack 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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3003255790	WITKO INCORPORATED	Wolcott, IN, US
3008742818	PT. Hisamitsu Pharma Indonesia	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014065673. Last updated year: 2026. Please use registration number 3014065673 when referencing this establishment in official correspondence.