Cleared Abbreviated

PowerDot PD-01MT (K181759) - FDA 510(k) Clearance

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

K181759 · Smartmissimo Technologies Pte, Ltd. · Physical Medicine device
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Nov 2018
Decision
130d
Days
Class 2
Risk

K181759 is an FDA 510(k) clearance for the PowerDot PD-01MT. 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 November 9, 2018 after a review of 130 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smartmissimo Technologies Pte, Ltd. devices

Submission Details

510(k) Number K181759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 2018
Decision Date November 09, 2018
Days to Decision 130 days
Submission Type Abbreviated
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
15d slower than avg
Panel avg: 115d · This submission: 130d
Pathway characteristics
Standards-based clearance path.

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
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