Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K222709
Retraction, CWM-910T, APOLEX Tite · Chungwoo Co., Ltd. · decided 2023-03-21 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Retraction | CWM-910T | Chungwoo Co., Ltd. | GEI | 08809495931156 |
| Hand Piece SMART | HP20-180 | Chungwoo Co., Ltd. | GEI | 08809495931378 |
| FOOT Switch | CWM-910T-H21 | Chungwoo Co., Ltd. | GEI | 08809495931101 |
| APOLEX Tite | CWM-910T | Chungwoo Co., Ltd. | GEI | 08809495931095 |
| Electrode LIFT | 2X80 | Chungwoo Co., Ltd. | GEI | 08809495931330 |
| Neutral Pad | 9541C | Chungwoo Co., Ltd. | GEI | 08809495931200 |
| Hand Piece LIPO | HP40-300 | Chungwoo Co., Ltd. | GEI | 08809495931385 |
| power cable | SP-30H,IS-14 | Chungwoo Co., Ltd. | GEI | 08809495931293 |
| APOLEX Tite, Retraction | CWM-910T | Chungwoo Co., Ltd. | GEI | 08809495931002 |
| Hand Piece Electrode SMART | AE20-180 | Chungwoo Co., Ltd. | GEI | 08809495931316 |
| Neutral Cable | CWM-910T-H22-1 | Chungwoo Co., Ltd. | GEI | 08809495931194 |
| Electrode SMART | 2X180 | Chungwoo Co., Ltd. | GEI | 08809495931347 |
| Electrode LIPO | 4X300 | Chungwoo Co., Ltd. | GEI | 08809495931354 |
| Hand Piece Electrode LIFT | AE20-80 | Chungwoo Co., Ltd. | GEI | 08809495931309 |
| Electrode SMART | AE20-180 | Chungwoo Co., Ltd. | GEI | 08809495931170 |
| Hand Piece LIFT | HP20-80 | Chungwoo Co., Ltd. | GEI | 08809495931361 |
| Hand Piece Electrode LIPO | AE40-300 | Chungwoo Co., Ltd. | GEI | 08809495931323 |
| Electrode LIPO | AE40-300 | Chungwoo Co., Ltd. | GEI | 08809495931187 |
| Electrode LIFT | AE20-80 | Chungwoo Co., Ltd. | GEI | 08809495931163 |