510(k) K252816
K252816 is an FDA 510(k) premarket notification submitted by Mohammadali Nezakati for the device "High Tone Power therapy (HiToP) (Model: HiToP PNP)". The FDA issued a decision of Substantially Equivalent on June 2, 2026. 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
- June 2, 2026
- Date Received
- September 4, 2025
- 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