Cleared Traditional

K900823 - ISOTRON 220

K900823 is an FDA 510(k) clearance for ISOTRON 220, manufactured by Excel Tech. , Ltd.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K900823 · Excel Tech. , Ltd. · Physical Medicine device
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Mar 1990
Decision
34d
Days
Class 2
Risk

K900823 is an FDA 510(k) clearance for the ISOTRON 220. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Excel Tech. , Ltd. (Oakville,Ontario, CA). The FDA issued a Cleared decision on March 26, 1990 after a review of 34 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 Tech. , Ltd. devices

FDA 510(k) Submission Details - K900823

510(k) Number K900823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1990
Decision Date March 26, 1990
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
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 258
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K900823.
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INTELECT 775MP POWERED MUSCLE STIMULATOR
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EMS 8100
K895301 · Henley Intl. · Feb 1990
MULTISTIM PLUS
K895983 · Excel Tech. , Ltd. · Feb 1990