Identity
- Trade Name
- Neutral Pad FDA UDI
- Generic Name
- Electrode conductive skin pad, single-use FDA UDI
- Model / Reference
- 9541C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809495931200 FDA UDI
- 510(k) Number
- K222709 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrode conductive skin pad, single-use 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrode conductive skin pad, single-use
Neutral Pad by Chungwoo Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 91d6d884-0fa9-4e3b-9e78-6f5386b998f7 34 fields · synced May 30, 2026