FDA Registration
Active
🇺🇸 United States
TruEMS
Reg #: 3032062344
·
FEI: 3032062344
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- TRUMEDX LLC
- Registration Number
- 3032062344
- FEI Number
- 3032062344
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 40 Pershing Drive
- City
- Derby
- State
- CT
- ZIP
- 06418
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191151
Owner / Operator
- Firm Name
- TrumedX LLC
- Operator Number
- 10091324
- Address
- 1 Parrott Dr
- City
- Shelton
- State
- CT
- Postal Code
- 06484
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2025-03-21 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2025-03-21 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2025-03-21 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2025-03-21 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2025-03-21 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2025-03-21 |
Proprietary Names
TruEMS
Establishment Types
Complaint File Establishment per 21 CFR 820.198