Identity
- Trade Name
- Single channel Foot Switch FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- The foot switch is used to turn RF energy on/off and to start/stop the cooling pump operation. FDA UDI
- Model / Reference
- FS-1P FDA UDI
- Description
- The foot switch is used to turn RF energy on/off and to start/stop the cooling pump operation. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809295145807 FDA UDI
- 510(k) Number
- K180999 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Foot-switch, electrical 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 290 Gram FDA UDI
Category: Foot-switch, electrical
Single channel Foot Switch by RF Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K180999 also covers:
- 2-Pin Dispersive Electrode cable — RF Medical Co., Ltd.
- Cooling pump — RF Medical Co., Ltd.
- Dual Foot Switch — RF Medical Co., Ltd.
- RF ABLATION SYSTEM V-1000 — RF Medical Co., Ltd.
- RFT Electrode — RF Medical Co., Ltd.
- RFT Electrode — RF Medical Co., Ltd.
- RFT Electrode — RF Medical Co., Ltd.
- RFT Electrode — RF Medical Co., Ltd.
- RFT Electrode — RF Medical Co., Ltd.
- RFT Electrode — RF Medical Co., Ltd.
- THYBLATE™ — RF Medical Co., Ltd.
- THYBLATE™ — RF Medical Co., Ltd.
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
- RF Medical Co., Ltd.
Sources (1)
- FDA UDI b487d146-db29-4a8f-9415-52a09f61f0e8 36 fields · synced May 31, 2026