Cleared Traditional

BODYFLOW P2CH (K100862) - FDA 510(k) Clearance

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

K100862 · Physiomed Elektromedizin AG · Physical Medicine device
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Apr 2011
Decision
388d
Days
Class 2
Risk

K100862 is an FDA 510(k) clearance for the BODYFLOW P2CH. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Physiomed Elektromedizin AG (Schnaittach/Laipersdorf, DE). The FDA issued a Cleared decision on April 21, 2011 after a review of 388 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 Physiomed Elektromedizin AG devices

Submission Details

510(k) Number K100862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2010
Decision Date April 21, 2011
Days to Decision 388 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 115d · This submission: 388d
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 Peers - IPF Stimulator, Muscle, Powered

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