Cleared Traditional

K896908 - EXCEL STIM II

K896908 is an FDA 510(k) clearance for EXCEL STIM II, manufactured by Excel U.S.A.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K896908 · Excel U.S.A. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
71d
Days
Class 2
Risk

K896908 is an FDA 510(k) clearance for the EXCEL STIM II. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Excel U.S.A. (Canada L4w 257, CA). The FDA issued a Cleared decision on February 20, 1990 after a review of 71 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 Excel U.S.A. devices

FDA 510(k) Submission Details - K896908

510(k) Number K896908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1989
Decision Date February 20, 1990
Days to Decision 71 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
44d faster than avg
Panel avg: 115d · This submission: 71d
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 273
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K896908.
EMS 8100
K895301 · Henley Intl. · Feb 1990
MULTISTIM PLUS
K895983 · Excel Tech. , Ltd. · Feb 1990
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
IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT
K893994 · Rich-Mar Corp. · Dec 1989