FDA Registration
Active
🇺🇸 United States
Revitive Medic Coach (Model Number 5575AQ)
Reg #: 3011501130
·
FEI: 3011501130
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Actegy Health Inc.
- Registration Number
- 3011501130
- FEI Number
- 3011501130
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7320 NW 12th Street,, Suite 103 Doral,
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
Regulatory Submissions
- 510(k) Number
- K210825
Owner / Operator
- Firm Name
- Actegy Ltd.
- Operator Number
- 10044804
- Address
- West Point, Western Road
- City
- Bracknell
- State
- GB-NOTA
- Postal Code
- RG12 1HJ
- Country
- GB
- Correspondent
- Roseanna Penny
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2021-12-17 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2021-12-17 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2021-12-17 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2021-12-17 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2021-12-17 |
Proprietary Names
Revitive Medic Coach (Model Number 5575AQ)
Establishment Types
Complaint File Establishment per 21 CFR 820.198