Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008562183

FEI Number

3008562183

Entity Name

Shanghai Gel King Technology Co., LTD

City/State/Country

Qidong Jiangsu, CN

Establishment Address

No.256 BeiXin Huangchang Town, Qidong Jiangsu 226226, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Gel King Technology Co., LTD (Owner Number: 10036846)

Owner / Operator Contact Address

Building 1, No 5885, Long Dong Avenue, Pudong New Area, Shanghai, CN-SH 201201, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MATTRESS, FLOTATION THERAPY, NON-POWERED Ice Bag, Ice Pouch Gel Cushion Gel Mat Cushion, Sponge Cushion Hot Cold Pack Hot Pack Ice Pack Gel Pad Instant hot pack Cushion KN95 MASK DISPOSABLE MASK FACE SHIELD DAILY PROTECTIVE MASK MASK Protective Mask Chiller, Protective Mask Cooling Pad Instant ice pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	2021-06-01
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2021-05-21
LRL	Cushion, Hemorrhoid	Unknown	Class U	N/A	2021-05-21
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2011-06-01
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2021-07-19
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-01
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2021-06-01

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

Shanghai Gel King Technology 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 3008562183. Last updated year: 2026. Please use registration number 3008562183 when referencing this establishment in official correspondence.