FDA Registration
Active
🇺🇸 United States
PowerDot PD-01M2 MuscleStimulator
Reg #: 3012386142
·
FEI: 3012386142
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Therabody, Inc.
- Registration Number
- 3012386142
- FEI Number
- 3012386142
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1640 S Sepulveda Blvd, Suite 300
- City
- Los Angeles
- State
- CA
- ZIP
- 90025
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210938
Owner / Operator
- Firm Name
- Therabody, Inc.
- Operator Number
- 10054050
- Address
- 1640 S Sepulveda Blvd, Suite 300
- City
- Los Angeles
- State
- CA
- Postal Code
- 90025
- Country
- US
- Correspondent
- CJ Frederick, III
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2022-03-11 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2022-03-11 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2022-03-11 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2022-03-11 |
Proprietary Names
PowerDot PD-01M2 MuscleStimulator
PowerDot 2
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198