Cleared Traditional

K213655 - HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K213655 · Hilltek, LLC · Physical Medicine device
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Jan 2023
Decision
424d
Days
Class 2
Risk

K213655 is an FDA 510(k) clearance for the HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch). Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Hilltek, LLC (Anaheim, US). The FDA issued a Cleared decision on January 17, 2023 after a review of 424 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Hilltek, LLC devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
309d slower than avg
Panel avg: 115d · This submission: 424d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Physical Medicine devices follow this clearance model.

Regulatory Consultant

Medical Device Academy, Inc.
Bhoomika Joyappa

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IPF Stimulator, Muscle, Powered

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