Cleared Traditional

K874736 - RICH-MAR HV-2000 ELECTRICAL MUSCLE STIM...

K874736 is the FDA 510(k) clearance for RICH-MAR HV-2000 ELECTRICAL MUSCLE STIM... by Rich-Mar Corp.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K874736 · Rich-Mar Corp. · Physical Medicine device
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Jan 1988
Decision
65d
Days
Class 2
Risk

K874736 is an FDA 510(k) clearance for the RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Rich-Mar Corp. (Inola, US). The FDA issued a Cleared decision on January 22, 1988 after a review of 65 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rich-Mar Corp. devices

Submission Details

510(k) Number K874736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1987
Decision Date January 22, 1988
Days to Decision 65 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 115d · This submission: 65d
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

All 156
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K874736.
INTELECT MODEL 120
K880235 · Chattanooga Group, Inc. · Apr 1988
GV 11 (TM), MODEL 9700
K881082 · Medical Devices, Inc. · Mar 1988
INTELECT VMS 2, OR INTELECT VMS II
K880234 · Chattanooga Group, Inc. · Feb 1988
RICH-MAR CONDUCTIVE GEL
K872036 · Rich-Mar Corp. · Nov 1987
INTELECT 775
K872655 · Chattanooga Group, Inc. · Nov 1987
MYOSTIM(TM), MODEL 6600
K872753 · Medical Devices, Inc. · Oct 1987