K170205 is an FDA 510(k) clearance for the Low-Frequency Therapy Instrument /Model: KTR-201, KTR-202, KTR-203. This device is classified as a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II - Special Controls, product code NUH).
Submitted by Shenzhen Kentro Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 11, 2017, 108 days after receiving the submission on January 23, 2017.
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 | K170205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 23, 2017 |
| Decision Date | May 11, 2017 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| 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 |