FDA Registration
Active
🇨🇳 China
Danyang Rapid Aid Hot and Cold Therapy Products Co. Ltd
Reg #: 3008955719
·
FEI: 3008955719
·
Expires 2026
Products
6
Proprietary Names
27
Establishment Types
7
Classifications
6
Registration Details
- Registration Name
- Danyang Rapid Aid Hot and Cold Therapy Products Co. Ltd
- Registration Number
- 3008955719
- FEI Number
- 3008955719
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Glasses Industrial Park, Danfu Road
- City
- Danyang Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K163295
Owner / Operator
- Firm Name
- Rapid Aid Corp.
- Operator Number
- 10028086
- Address
- 4120A Sladeview Crescent
- City
- Mississauga
- State
- Ontario
- Postal Code
- L5L5Z3
- Country
- CA
US Agent
- Business Name
- Mandell Horwitz Consultants LLC
- Contact Name
- Diane Horwitz
- Address
- 5 Lake Como Ct
- City
- Greenville
- State
- SC
- ZIP
- 29609
- Country
- US
- [email protected]
- Phone
- 703 3072921
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2008-12-29 |
| Adhesive Backed Thermal Skin Patches | OMW | Class 1 | Physical Medicine | No | 2024-01-22 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2020-05-22 |
| Infant Heel Warmer (Chemical Heat Pack) | MPO | Class 1 | Physical Medicine | No | 2008-12-29 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-04-08 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2008-12-29 |
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
Rapid Aid Face Shield
Calf/Shin Pack
Ankle Pack
Natural Therapeutic Oat bag
Reusable Hot & Cold Compress Wrap
Foot Pain Cold Pack
Achilles Pack
Reusable Hot & Cold Gel Pack
Plantar Pack
Cold Pocket
Reusable Cold Gel Pack
Cold Slipper
Dorsum Pack
Establishment Types
Foreign Private Label Distributor
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility