K001117 is an FDA 510(k) clearance for the COMFORT STIM. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by R & D Medical Products, Inc. (Lake Forest, US). The FDA issued a Cleared decision on July 5, 2000, 90 days after receiving the submission on April 6, 2000.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K001117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2000 |
| Decision Date | July 05, 2000 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |