Cleared Traditional

K872655 - INTELECT 775

K872655 is an FDA 510(k) clearance for INTELECT 775, manufactured by Chattanooga Group, Inc.. The device is a Class 2 Physical Medicine device with product code IPF cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K872655 · Chattanooga Group, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1987
Decision
119d
Days
Class 2
Risk

K872655 is an FDA 510(k) clearance for the INTELECT 775. Classified as Stimulator, Muscle, Powered (product code IPF), Class II - Special Controls.

Submitted by Chattanooga Group, Inc. (Red Bank, US). The FDA issued a Cleared decision on November 3, 1987 after a review of 119 days - within the typical 510(k) review window.

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 Chattanooga Group, Inc. devices

FDA 510(k) Submission Details - K872655

510(k) Number K872655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1987
Decision Date November 03, 1987
Days to Decision 119 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
4d slower than avg
Panel avg: 115d · This submission: 119d
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 156
Devices cleared under the same product code (IPF) and FDA review panel - the closest regulatory comparables to K872655.
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
MYOSTIM(TM), MODEL 6600
K872753 · Medical Devices, Inc. · Oct 1987
INTELECT MODEL 575
K872654 · Chattanooga Group, Inc. · Sep 1987
DYNATRON 438
K870515 · Henley Intl. · Jun 1987