Cleared Traditional

K895301 - EMS 8100

K895301 is the FDA 510(k) clearance for EMS 8100 by Henley Intl.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K895301 · Henley Intl. · Physical Medicine device
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Feb 1990
Decision
179d
Days
Class 2
Risk

K895301 is an FDA 510(k) clearance for the EMS 8100. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on February 20, 1990 after a review of 179 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 Henley Intl. devices

Submission Details

510(k) Number K895301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1989
Decision Date February 20, 1990
Days to Decision 179 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
64d slower than avg
Panel avg: 115d · This submission: 179d
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 134
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K895301.
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MULTISTIM PLUS
K895983 · Excel Tech. , Ltd. · Feb 1990
EXCEL STIM
K896836 · Excel Tech. , Ltd. · Feb 1990
IF2000 ELECTRICAL MUSCLE STIMULATOR UNIT
K893994 · Rich-Mar Corp. · Dec 1989