K141076 is an FDA 510(k) clearance for the GARMENT ELECTRODES. This device is classified as a Electrode, Cutaneous (Class II - Special Controls, product code GXY).
Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on November 14, 2014, 203 days after receiving the submission on April 25, 2014.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.1320.
| 510(k) Number | K141076 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2014 |
| Decision Date | November 14, 2014 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GXY — Electrode, Cutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.1320 |