Cleared Traditional

K952163 - DAVID BACK CLINIC SYSTEM

K952163 is an FDA 510(k) clearance for DAVID BACK CLINIC SYSTEM, manufactured by Kinetic Resources, Inc.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 462-day FDA review.

K952163 · Kinetic Resources, Inc. · Physical Medicine device
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Aug 1996
Decision
462d
Days
Class 2
Risk

K952163 is an FDA 510(k) clearance for the DAVID BACK CLINIC SYSTEM. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Kinetic Resources, Inc. (Fort Worth, US). The FDA issued a Cleared decision on August 12, 1996 after a review of 462 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Kinetic Resources, Inc. devices

FDA 510(k) Submission Details - K952163

510(k) Number K952163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date August 12, 1996
Days to Decision 462 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
347d slower than avg
Panel avg: 115d · This submission: 462d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ISD Device Classification - Class 2, Special Controls

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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 - ISD Exerciser, Measuring

All 25
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K952163.
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K926287 · Henley Intl. · Mar 1994