Identity
- Trade Name
- Replexa+ Device FDA UDI
- Generic Name
- Short-wave diathermy treatment system, professional FDA UDI
- Device Name
- Replexa+ Model C1416 Shortwave Diathermy Device FDA UDI
- Model / Reference
- C1416 FDA UDI
- Description
- Replexa+ Model C1416 Shortwave Diathermy Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850886008009 FDA UDI
- 510(k) Number
- K162240 FDA UDI
- FDA Product Code
- IMJ FDA UDI
- GMDN Term
- Short-wave diathermy treatment system, professional FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5290 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Short-wave diathermy treatment system, professional
Replexa+ Device by Promedtek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Short-wave diathermy treatment system, professional.
- Auto*Therm 390 — METTLER ELECTRONICS CORP. · Class II
- Replexa+ Treatment Applicator — Promedtek, Inc. · Class II
Cleared under the same submission
K162240 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Promedtek, Inc.
Sources (1)
- FDA UDI 5ad6fd6d-4b2f-44c1-be4a-8b9e6409dda5 35 fields · synced Jun 8, 2026