Identity
- Trade Name
- Electrode LIFT FDA UDI
- Generic Name
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
- Model / Reference
- AE20-80 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809495931163 FDA UDI
- 510(k) Number
- K222709 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- Not 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
Moist Heat or Steam Sterilization FDA UDI
Electrode LIFT by Chungwoo Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K222709 also covers:
- APOLEX Tite — Chungwoo Co., Ltd.
- APOLEX Tite, Retraction — Chungwoo Co., Ltd.
- Electrode LIFT — Chungwoo Co., Ltd.
- Electrode LIPO — Chungwoo Co., Ltd.
- Electrode SMART — Chungwoo Co., Ltd.
- FOOT Switch — Chungwoo Co., Ltd.
- Hand Piece Electrode LIFT — Chungwoo Co., Ltd.
- Hand Piece Electrode LIPO — Chungwoo Co., Ltd.
- Hand Piece Electrode SMART — Chungwoo Co., Ltd.
- Hand Piece LIFT — Chungwoo Co., Ltd.
- Hand Piece LIPO — Chungwoo Co., Ltd.
- Hand Piece SMART — Chungwoo 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 |
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Manufacturer
- Manufacturer
- Chungwoo Co., Ltd.
Sources (1)
- FDA UDI 27c8b29d-f20c-482c-885b-ec58e84b13d4 35 fields · synced Jun 1, 2026