Cleared Traditional

K872606 - TELESONIC BODY STIMULATOR

K872606 is the FDA 510(k) clearance for TELESONIC BODY STIMULATOR by Telesonic, Inc.. It is a Class 2 Physical Medicine device (product code IPF) cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K872606 · Telesonic, Inc. · Physical Medicine device
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Dec 1987
Decision
173d
Days
Class 2
Risk

K872606 is an FDA 510(k) clearance for the TELESONIC BODY STIMULATOR. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Telesonic, Inc. (Fort Lauderdale, US). The FDA issued a Cleared decision on December 22, 1987 after a review of 173 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 Telesonic, Inc. devices

Submission Details

510(k) Number K872606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1987
Decision Date December 22, 1987
Days to Decision 173 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
58d slower than avg
Panel avg: 115d · This submission: 173d
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 146
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K872606.
GV 11 (TM), MODEL 9700
K881082 · Medical Devices, Inc. · Mar 1988
INTELECT VMS 2, OR INTELECT VMS II
K880234 · Chattanooga Group, Inc. · Feb 1988
RICH-MAR HV-2000 ELECTRICAL MUSCLE STIMULATOR
K874736 · Rich-Mar Corp. · Jan 1988
RICH-MAR CONDUCTIVE GEL
K872036 · Rich-Mar Corp. · Nov 1987
INTELECT 775
K872655 · Chattanooga Group, Inc. · Nov 1987
MYOSTIM(TM), MODEL 6600
K872753 · Medical Devices, Inc. · Oct 1987