Cleared Traditional

K233098 - MYOTouch Muscle Stimulator

K233098 is an FDA 510(k) clearance for MYOTouch Muscle Stimulator, manufactured by Sunmed, LLC. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K233098 · Sunmed, LLC · Physical Medicine device
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Aug 2024
Decision
311d
Days
Class 2
Risk

K233098 is an FDA 510(k) clearance for the MYOTouch Muscle Stimulator. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Sunmed, LLC (Grand Rapids, US). The FDA issued a Cleared decision on August 2, 2024 after a review of 311 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunmed, LLC devices

FDA 510(k) Submission Details - K233098

510(k) Number K233098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date August 02, 2024
Days to Decision 311 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
196d slower than avg
Panel avg: 115d · This submission: 311d
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IPF Stimulator, Muscle, Powered

All 165
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K233098.
Quantum Mitohormesis (QMT) (M2101)
K240348 · Quantumtx Pte. , Ltd. · Dec 2024
eMVFit (MVF-10M)
K240992 · Weero Co., Ltd. · Oct 2024
BTL-899MS
K240234 · BTL Industries, Inc. · Aug 2024
Stimulation System (PA series, PR series, S series and Q series)
K232786 · Edan Instruments, Inc. · May 2024
accufit
K233926 · Mettler Electronics Corporation · Mar 2024
M-Wave
K233485 · Zynex Medical, Inc. · Jan 2024