Cleared Traditional

K100862 - BODYFLOW P2CH

K100862 is an FDA 510(k) clearance for BODYFLOW P2CH, manufactured by Physiomed Elektromedizin AG. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 388-day FDA review.

K100862 · Physiomed Elektromedizin AG · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K100862

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
272d slower than avg
Panel avg: 116d · This submission: 388d
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 505
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K100862.
RS-4I MUSCLE STIMULATOR
K112348 · Rs Medical · Jan 2012
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K092202 · Eswallow USA · Feb 2011
GS 3000
K102202 · Emsi · Nov 2010
EMPI CONTINUUM
K093324 · Empi · Mar 2010
K100862 · BODYFLOW P2CH
Download PDF FDA Summary Physiomed Elektromedi…