K213655 is an FDA 510(k) clearance for the HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch). This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Hilltek, LLC (Anaheim, US). The FDA issued a Cleared decision on January 17, 2023, 424 days after receiving the submission on November 19, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K213655 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 19, 2021 |
| Decision Date | January 17, 2023 |
| Days to Decision | 424 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IPF - Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |