510(k) K213655
K213655 is an FDA 510(k) premarket notification submitted by Hilltek, LLC for the device "HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)". The FDA issued a decision of Substantially Equivalent on Jan 17, 2023. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 17, 2023
- Date Received
- Nov 19, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type
- 510(k)