The following data is part of a premarket notification filed by Well-life Healthcare Limited with the FDA for If Series True Sine Interferential Stimulator, Model: Wl-2206b And Wl-2106e.
| Device ID | K090023 |
| 510k Number | K090023 |
| Device Name: | IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E |
| Classification | Interferential Current Therapy |
| 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 | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-05 |
| Decision Date | 2009-01-30 |
| Summary: | summary |