Cleared Traditional

K252816 - High Tone Power therapy (HiToP) (Model: HiToP PNP)

K252816 is an FDA 510(k) clearance for High Tone Power therapy (HiToP) (Model:..., manufactured by Mohammadali Nezakati. The device is a Class 2 Neurology device with product code IPF cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K252816 · Mohammadali Nezakati · Neurology device
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Jun 2026
Decision
271d
Days
Class 2
Risk

K252816 is an FDA 510(k) clearance for the High Tone Power therapy (HiToP) (Model: HiToP PNP). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Mohammadali Nezakati (Sherman Oaks, US). The FDA issued a Cleared decision on June 2, 2026 after a review of 271 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 890.5850 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mohammadali Nezakati devices

FDA 510(k) Submission Details - K252816

510(k) Number K252816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2025
Decision Date June 02, 2026
Days to Decision 271 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 148d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPF Device Classification - Class 2, Special Controls

Product Code IPF Stimulator, Muscle, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 257
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