Submission Details
| 510(k) Number | K252236 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 2025 |
| Decision Date | August 15, 2025 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
K252236 is an FDA 510(k) clearance for the CP Relief Wand Rx - TENS/NMES, a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by N & C Holdings, LLC (Jefferson City, US). The FDA issued a Cleared decision on August 15, 2025, 29 days after receiving the submission on July 17, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K252236 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 2025 |
| Decision Date | August 15, 2025 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5890 |