K052785 is an FDA 510(k) clearance for the OTC TENS FOR LOW BACK PAIN RELIEF, MODEL WL-2405 AND WL-2406. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Well-Life Healthcare Limited (Kowloon, HK). The FDA issued a Cleared decision on March 17, 2006, 165 days after receiving the submission on October 3, 2005.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890. Temporary Relief Of Pain Due To Sore/aching Muscles.
| 510(k) Number | K052785 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2005 |
| Decision Date | March 17, 2006 |
| Days to Decision | 165 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |
| Definition | Temporary Relief Of Pain Due To Sore/aching Muscles |