K182682 is an FDA 510(k) clearance for the OrthoGold 100. This device is classified as a Massager, Therapeutic, Electric (Class I - General Controls, product code ISA).
Submitted by Tissue Regeneration Technologies (Woodstock, US). The FDA issued a Cleared decision on December 21, 2018, 86 days after receiving the submission on September 26, 2018.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5660.
| 510(k) Number | K182682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2018 |
| Decision Date | December 21, 2018 |
| Days to Decision | 86 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 |