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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 2612 Sirius Drive, Denton, TX, 76208
- Website
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3011767724
- DUNS Number
- —
Catalogue (214)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| ManaMed | Cabo Knee XX-Large Left | FDA UDI | Class I | Active |
| ManaMed | ManaEZ Hinged Knee Brace Medium | FDA UDI | Class I | Active |
| ManaMed | ManaForceOA, LFT | FDA UDI | Class I | Unknown |
| ManaMed | ManaEZ Boot Air Short XS | FDA UDI | Class I | Active |
| ManaMed Transducer Fixation Strap | MTWTSTRAP | FDA UDI | Class II | Active |
| Tailback2-64 | TB064-2 | FDA UDI | Class I | Active |
| PlasmaWave | K211253 | FDA 510(k) | Class II | Active |
| PlasmaFlight | K200351 | FDA 510(k) | Class II | Active |
| ManaFlexx 2 (model: MF002-RX, MF002-OTC) | K231569 | FDA 510(k) | Class II | Active |
| PlasmaFlow | K160318 | FDA 510(k) | Class II | Active |
| PlasmaFlow X Compression Sleeve Device (XPF0001) | K251446 | FDA 510(k) | Class II | Active |
| ManaSport | K210284 | FDA 510(k) | Class II | Active |
| ManaSport+ | K222098 | FDA 510(k) | Class II | Active |
| ManaFlow | K200353 | FDA 510(k) | Class II | Active |
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