510(k) K252816

High Tone Power therapy (HiToP) (Model: HiToP PNP) by Mohammadali Nezakati — Product Code IPF

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