K210166 is an FDA 510(k) clearance for the Omnispec ED1000. This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).
Submitted by Medispec, Ltd. (Gaithersburg, US). The FDA issued a Cleared decision on January 27, 2023, 736 days after receiving the submission on January 21, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K210166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2021 |
| Decision Date | January 27, 2023 |
| Days to Decision | 736 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ISA - Massager, Therapeutic, Electric |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5660 |