Cleared Traditional

K091791 - PROVANT SYSTEM, MODEL 4201

K091791 is an FDA 510(k) clearance for PROVANT SYSTEM, manufactured by Regenesis Biomedical, Inc.. The device is a Class 2 Physical Medicine device with product code ILX cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K091791 · Regenesis Biomedical, Inc. · Physical Medicine device
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Apr 2010
Decision
294d
Days
Class 2
Risk

K091791 is an FDA 510(k) clearance for the PROVANT SYSTEM, MODEL 4201. Classified as Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (product code ILX), Class II - Special Controls.

Submitted by Regenesis Biomedical, Inc. (Scottsdale, US). The FDA issued a Cleared decision on April 7, 2010 after a review of 294 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5290 - 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. Standard predicate reliance. 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 Regenesis Biomedical, Inc. devices

FDA 510(k) Submission Details - K091791

510(k) Number K091791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2009
Decision Date April 07, 2010
Days to Decision 294 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
178d slower than avg
Panel avg: 116d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILX Device Classification - Class 2, Special Controls

Product Code ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5290
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 - ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

All 12
Devices cleared under the same product code (ILX) and FDA review panel - the closest regulatory comparables to K091791.
PROVANT THERAPY SYSTEM
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ZEOBI
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ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE
K092044 · Orthocor Medical · Dec 2009
ORTHOCOR KNEE SYSTEM BASIC
K091996 · Orthocor Medical · Dec 2009
IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II
K070541 · Ivivi Technologies, Inc. · Dec 2008