The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for Otc Abdomen & Thigh System, Model: Wl-2410, Wl-2411 And Wl-2412.
| Device ID | K072168 |
| 510k Number | K072168 |
| Device Name: | OTC ABDOMEN & THIGH SYSTEM, MODEL: WL-2410, WL-2411 AND WL-2412 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW |
| Contact | Jenny Hsieh |
| Correspondent | Jenny Hsieh WELL-LIFE HEALTHCARE LIMITED 1FL, NO.16, LANE 454 JUNGJENG RD. Yunghe City, Taipei County, TW |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-06 |
| Decision Date | 2007-12-19 |
| Summary: | summary |