FDA Registration
Active
🇺🇸 United States
TRUMEDX LLC
Reg #: 3032062344
·
FEI: 3032062344
·
Expires 2026
Products
14
Proprietary Names
14
Establishment Types
1
Classifications
14
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Registration Details
- Registration Name
- TRUMEDX LLC
- Registration Number
- 3032062344
- FEI Number
- 3032062344
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1 Parrott Dr Ste 400
- City
- Shelton
- State
- CT
- ZIP
- 06484
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240011
Owner / Operator
- Firm Name
- TrumedX LLC
- Operator Number
- 10091324
- Address
- 1 Parrott Dr
- City
- Shelton
- State
- CT
- Postal Code
- 06484
- Country
- US
- Correspondent
- Bill Dai
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Joint, Shoulder, External Limb Component | IQQ | Class 1 | Physical Medicine | No | 2025-03-21 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2025-03-21 |
| Sling, Arm | ILI | Class 1 | Physical Medicine | No | 2025-03-13 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2026-05-12 |
| Joint, Hip, External Brace | ITS | Class 1 | Physical Medicine | No | 2025-03-21 |
| Massager, Powered Inflatable Tube | IRP | Class 2 | Physical Medicine | No | 2026-05-29 |
| Pack, Hot Or Cold, Water Circulating | ILO | Class 2 | Physical Medicine | No | 2026-05-29 |
| Joint, Knee, External Brace | ITQ | Class 1 | Physical Medicine | No | 2025-03-21 |
| 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
MOBIL-IZE Shoulder
TruEDEMA
Slinger 90 TRU-X10790
Slinger TRU-X107
TruLuminate
MOBIL-IZE Cryo Hip
TruMedX Wraps
MOBIL-IZE KNEE
TruEMS
TruDVT Slide
TruDVT
TruDVT GO
Bighorn Ice
Bighorn Ice Plus
Establishment Types
Complaint File Establishment per 21 CFR 820.198