Cleared Traditional

K961212 - SPINAL TOUCH

K961212 is an FDA 510(k) clearance for SPINAL TOUCH, manufactured by Fasstech. The device is a Class 1 Neurology device with product code KQX cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K961212 · Fasstech · Neurology device
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Jun 1996
Decision
76d
Days
Class 1
Risk

K961212 is an FDA 510(k) clearance for the SPINAL TOUCH. Classified as Goniometer, Ac-powered (product code KQX), Class I - General Controls.

Submitted by Fasstech (Burlington, US). The FDA issued a Cleared decision on June 12, 1996 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 888.1500 - the FDA neurology 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 Fasstech devices

FDA 510(k) Submission Details - K961212

510(k) Number K961212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1996
Decision Date June 12, 1996
Days to Decision 76 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 148d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

KQX Device Classification - Class 1, General Controls

Product Code KQX Goniometer, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KQX Goniometer, Ac-powered

All 8
Devices cleared under the same product code (KQX) and FDA review panel - the closest regulatory comparables to K961212.
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
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SPINE MOTION ANALYZER WITH EMG
K920256 · Orthopedic Systems, Inc. · Aug 1992
DYNATRON 360 RANGE OF MOTION TESTING DEVICE
K897178 · Dynatronics Corp. · Apr 1990
COMPREHENSIVE SPINE MOTION ANALYZER
K894283 · Orthopedic Systems, Inc. · Jan 1990
HYPAL ADHESIVE TAPE
K832991 · Smith & Nephew, Inc. · Jan 1984