Cleared Traditional

K960489 - ULTRA IV

K960489 is the FDA 510(k) clearance for ULTRA IV by Excel Tech. , Ltd.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K960489 · Excel Tech. , Ltd. · Physical Medicine device
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Mar 1996
Decision
54d
Days
Class 2
Risk

K960489 is an FDA 510(k) clearance for the ULTRA IV. 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 27, 1996 after a review of 54 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

Submission Details

510(k) Number K960489 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 02, 1996
Decision Date March 27, 1996
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
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 K960489.
FORTE, MODELS CPS 400 STIM, CPS 200 STIM
K982828 · Chattanooga Group, Inc. · Nov 1998
MODEL PS-1 PENA MUSCLE STIMULATOR
K980448 · Radionics, Inc. · Apr 1998
ULTRA III
K960096 · Excel Tech. , Ltd. · Mar 1996
FORTE ES-400
K953615 · Chattanooga Group, Inc. · Oct 1995
MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR
K941049 · Smith & Nephew, Inc. · May 1994
GALVANIC GENERATOR MODEL IMF4150/A
K932916 · Biomedical Life Systems, Inc. · Jan 1994