Cleared Traditional

K940590 - MINTO SKIN TRACTION MOTOR
(FDA 510(k) Clearance)

Apr 1994
Decision
66d
Days
Class 2
Risk

K940590 is an FDA 510(k) clearance for the MINTO SKIN TRACTION MOTOR. This device is classified as a Equipment, Traction, Powered (Class II - Special Controls, product code ITH).

Submitted by Minto Research & Development, Inc. (Redding, US). The FDA issued a Cleared decision on April 15, 1994, 66 days after receiving the submission on February 8, 1994.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5900.

Submission Details

510(k) Number K940590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1994
Decision Date April 15, 1994
Days to Decision 66 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ITH — Equipment, Traction, Powered
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.5900

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