Cleared Traditional

K963480 - MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER
(FDA 510(k) Clearance)

K963480 · Deroyal Industries, Inc. · Physical Medicine

Jan 1997

Decision

141d

Days

Class 1

Risk

K963480 is an FDA 510(k) clearance for the MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER. This device is classified as a Restraint, Wheelchair, Non-protective (Class I — General Controls, product code KID).

Submitted by Deroyal Industries, Inc. (Knoxville, US). The FDA issued a Cleared decision on January 22, 1997, 141 days after receiving the submission on September 3, 1996.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3910.

Submission Details

510(k) Number	K963480 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 1996
Decision Date	January 22, 1997
Days to Decision	141 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF