Identity
- Trade Name
- RF Electrode FDA UDI
- Generic Name
- Medium-wave diathermy treatment system electrode, active FDA UDI
- Device Name
- Reusable Non-Invasive RF Electrode FDA UDI
- Model / Reference
- RFE-10-D FDA UDI
- Description
- Reusable Non-Invasive RF Electrode FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817371020069 FDA UDI
- 510(k) Number
- K130689 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Medium-wave diathermy treatment system electrode, active FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medium-wave diathermy treatment system electrode, active
RF Electrode by Thermi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medium-wave diathermy treatment system electrode, active.
- Thermi Disposable RF Electrode (Qty 1) — Celling Biosciences · Class II
- Thermi Reusable RF Electrode — Celling Biosciences · Class II
- Gyrus ACMI — Gyrus Acmi, Inc. · Class II
- Thermi Reusable RF Electrode — Celling Biosciences · Class II
- Thermi Reusable RF Electrode — Celling Biosciences · Class II
- Thermi Disposable RF Electrode (Qty 5) — Celling Biosciences · Class II
- Thermi Reusable RF Electrode — Celling Biosciences · Class II
- Thermi Reusable RF Electrode — Celling Biosciences · Class II
Cleared under the same submission
K130689 also covers:
- (Certified) ThermiRF+ — Celling Biosciences
- Arvati — Celling Biosciences
- Thermi Disposable RF Electrode (Qty 1) — Celling Biosciences
- Thermi Disposable RF Electrode (Qty 5) — Celling Biosciences
- Thermi Disposable RF Electrode (Qty 5) — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Thermi
Sources (1)
- FDA UDI c33db37f-abda-4a65-b95d-9c3f643ef0ec 34 fields · synced May 30, 2026