K212618 is an FDA 510(k) clearance for the iRelieve Microcurrent Pain Relief System. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Fast Track Technologies, Inc. (Newport Beach, US). The FDA issued a Cleared decision on September 14, 2022, 392 days after receiving the submission on August 18, 2021.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K212618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2021 |
| Decision Date | September 14, 2022 |
| Days to Decision | 392 days |
| Submission Type | Traditional |
| 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 |