Cleared Traditional

K961212 - SPINAL TOUCH
(FDA 510(k) Clearance)

K961212 · Fasstech · Neurology device

Jun 1996

Decision

76d

Days

Class 1

Risk

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

Submitted by Fasstech (Burlington, US). The FDA issued a Cleared decision on June 12, 1996, 76 days after receiving the submission on March 28, 1996.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.1500.

Submission Details

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