Cleared Traditional

K893994 - IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT

K893994 is the FDA 510(k) clearance for IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT by Rich-Mar Corp.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K893994 · Rich-Mar Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
192d
Days
Class 2
Risk

K893994 is an FDA 510(k) clearance for the IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT. 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 December 14, 1989 after a review of 192 days - an extended review 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: 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 Rich-Mar Corp. devices

Submission Details

510(k) Number K893994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1989
Decision Date December 14, 1989
Days to Decision 192 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
77d slower than avg
Panel avg: 115d · This submission: 192d
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 K893994.
EXCEL STIM
K896836 · Excel Tech. , Ltd. · Feb 1990
SYS*STIM 206A
K893878 · Mettler Electronics Corp. · Dec 1989
SYS*STIM 207A
K893879 · Mettler Electronics Corp. · Dec 1989
ELECTRO NEUROMUSCULAR STIMULATOR MODEL 2000
K884651 · Biomedical Life Systems, Inc. · Nov 1989
RICH-MAR CONDUCTIVE GEL II W/ALOE VERA
K890147 · Rich-Mar Corp. · Mar 1989
ENDOMED CV405
K880699 · Henley Intl. · May 1988