Kunshan Topgel Industry Co., Ltd

FDA Device Registration & Listing · Kunshan Jiangsu, CN · Registration 3011182985

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011182985
FEI Number
3011182985
Entity Name
Kunshan Topgel Industry Co., Ltd
City/State/Country
Kunshan Jiangsu, CN
Establishment Address
No.165 Xincui Road, Huaqiao Town, Kunshan Jiangsu 215332, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Kunshan Topgel Industry Co., Ltd (Owner Number: 10047619)
Owner / Operator Contact Address
No.165 Xincui Road, Huaqiao Town, Kunshan, CN-JS 215332, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Heat pack, TGH100 Instant cold pack Disposable, TGI200 Cold/hot pack, TGHC300

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IMA Pack, Heat, Moist Physical Medicine Class 1 890.5730 2014-10-13
IMD Pack, Hot Or Cold, Disposable Physical Medicine Class 1 890.5710 2015-12-24
IME Pack, Hot Or Cold, Reusable Physical Medicine Class 1 890.5700 2014-10-13

Official Correspondent

No official correspondent registered.

US Agent Details

Alex Gary Business: BTS US Inc Email: us@hibts.com Phone: (844) 9823583

Related Public Records

Same Entity

Kunshan Topgel Industry 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 3011182985. Last updated year: 2026. Please use registration number 3011182985 when referencing this establishment in official correspondence.
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