The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Buttock Muscle Stimulator Model Wl-2413b; Buttock Muscle Stimulator Mode Wl-2413e.
| Device ID | K123075 |
| 510k Number | K123075 |
| Device Name: | BUTTOCK MUSCLE STIMULATOR MODEL WL-2413B; BUTTOCK MUSCLE STIMULATOR MODE WL-2413E |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW Ch |
| Contact | Chin-chih Hsieh |
| Correspondent | Chin-chih Hsieh WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW Ch |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-01 |
| Decision Date | 2013-07-11 |
| Summary: | summary |