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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 149d · 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 31
Devices cleared under the same product code (KQX) and FDA review panel - the closest regulatory comparables to K961212.
ORTELIUS 800
K011827 · Orthoscan , Ltd. · Aug 2001
INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE
K971079 · Interlogics, Inc. · Jul 1997
3D-SPINE
K962377 · Skill Technologies, Inc. · Sep 1996
INCLINOMETER
K954647 · J-Tech, Inc. · Oct 1995
DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS)
K943929 · Greenleaf Medical Systems, Inc. · May 1995
LARGE MUSCLE STRENGTH GAUGE
K945630 · J-Tech, Inc. · May 1995
K961212 · SPINAL TOUCH
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