Cleared Special

PowerDot PD-01MT2 Muscle Stimulator (K210938) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210938 · Smartmissimo Technologies Pte, Ltd. · Physical Medicine device
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Jul 2021
Decision
123d
Days
Class 2
Risk

K210938 is an FDA 510(k) clearance for the PowerDot PD-01MT2 Muscle Stimulator. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Smartmissimo Technologies Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on July 30, 2021 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5850 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Smartmissimo Technologies Pte, Ltd. devices

Submission Details

510(k) Number K210938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2021
Decision Date July 30, 2021
Days to Decision 123 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 115d · This submission: 123d
Pathway characteristics
Modification to existing cleared device.

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 Peers - IPF Stimulator, Muscle, Powered

All 73
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K210938.
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