FDA Registration
Active
🇺🇸 United States
RHB1043 Tens Digital Massager
Reg #: 3011191255
·
FEI: 3011191255
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- VIVE Health LLC
- Registration Number
- 3011191255
- FEI Number
- 3011191255
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 8955 Fontana Del Sol Way
- City
- Naples
- State
- FL
- ZIP
- 34109
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183288
Owner / Operator
- Firm Name
- VIVE Health LLC
- Operator Number
- 10047487
- Address
- 8955 Fontana Del Sol Way
- City
- Naples
- State
- FL
- Postal Code
- 34109
- Country
- US
- Correspondent
- Joseph Fleming
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2022-11-09 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2022-11-09 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2022-11-09 |
Proprietary Names
RHB1043 Tens Digital Massager
Establishment Types
Repack or Relabel Medical Device