K092763 is an FDA 510(k) clearance for the IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D. This device is classified as a Interferential Current Therapy (Class II - Special Controls, product code LIH).
Submitted by Well-Life Healthcare Limited (Yunghe City, Taipei County, TW). The FDA issued a Cleared decision on October 8, 2009, 29 days after receiving the submission on September 9, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K092763 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2009 |
| Decision Date | October 08, 2009 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LIH — Interferential Current Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |