FDA Registration
Active
🇨🇳 China
Infant Heel Warmer
Reg #: 3008955719
·
FEI: 3008955719
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Danyang Rapid Aid Hot and Cold Therapy Products Co. Ltd
- Registration Number
- 3008955719
- FEI Number
- 3008955719
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Glasses Industrial Park, Danfu Road,
- City
- Danyang Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K040856
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 |
|---|---|---|---|---|---|
| Infant Heel Warmer (Chemical Heat Pack) | MPO | Class 1 | Physical Medicine | No | 2008-12-29 |
Proprietary Names
Infant Heel Warmer
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device