Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008955719

FEI Number

3008955719

Entity Name

Danyang Rapid Aid Hot and Cold Therapy Products Co. Ltd

City/State/Country

Danyang Jiangsu, CN

Establishment Address

Glasses Industrial Park, Danfu Road, Danyang Jiangsu 212300, CN

Establishment Type(s)

Foreign Private Label Distributor,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

Rapid Aid Corp. (Owner Number: 10028086)

Owner / Operator Contact Address

4120A Sladeview Crescent, Mississauga, CA-ON L5L5Z3, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K150627

PMA Number

N/A

All Registered Proprietary Names

Instant Warm Perineal Pack with self- adhesive strip Instant Cold Pack with self- adhering wrap Instant Cold Perineal Pack with self- adhesive strip Instant Extra Hot Pack Instant Hot Pack Instant Extra Warm Pack Instant Warm Pack Instant Cold Pack 35059 Instant Cold Pack Adhesive backed thermal skin patches Ice Bag Infant Transport Mattress Warmer Infant Heel Warmer Infant Heel Warmer, with Disc

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	2008-12-29
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2024-01-22
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2020-05-22
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2017-11-30
MPO	Infant Heel Warmer (Chemical Heat Pack)	Physical Medicine	Class 1	890.5710	2008-12-29
MPO	Infant Heel Warmer (Chemical Heat Pack)	Physical Medicine	Class 1	890.5710	2015-12-08

Official Correspondent

No official correspondent registered.

US Agent Details

Diane Horwitz Business: Mandell Horwitz Consultants LLC Email: dmh@mandellhorwitzconsulting.com Phone: (703) 3072921

Related Public Records

Same Entity

Rapid Aid Corp.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014982528	Rapid Aid Vietnam Co., Ltd	An Quang Commune Hai Phong, VN
3010039589	RAPID AID CORP.	Wilmington, DE, US
9710505	RAPID AID CORP.	MISSISSAUGA Ontario, CA
3038103734	Rapid Aid Corp.	Moberly, MO, US

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

Similar Registrations

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3031595576	SUZHOU SMH CO., LTD.	Suzhou Jiangsu, CN
3017103360	RAIN EYE DROPS LLC	Wilmington, DE, US
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 3008955719. Last updated year: 2026. Please use registration number 3008955719 when referencing this establishment in official correspondence.