Cleared Traditional

K895671 - STIMTRAC II CATALOG NUMBER 78-8500

K895671 is an FDA 510(k) clearance for STIMTRAC II CATALOG NUMBER 78-8500, manufactured by Stimtech Products. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K895671 · Stimtech Products · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
47d
Days
Class 2
Risk

K895671 is an FDA 510(k) clearance for the STIMTRAC II CATALOG NUMBER 78-8500. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Stimtech Products (Southbridge, US). The FDA issued a Cleared decision on November 6, 1989 after a review of 47 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 Stimtech Products devices

FDA 510(k) Submission Details - K895671

510(k) Number K895671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date November 06, 1989
Days to Decision 47 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 115d · This submission: 47d
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 158
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K895671.
SYS*STIM 207A
K893879 · Mettler Electronics Corp. · Dec 1989
IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT
K893994 · Rich-Mar 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
RICH-MAR G1000 EMS
K880948 · Rich-Mar Corp. · Apr 1988