Cleared Traditional

K823645 - VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR (FDA 510(k) Clearance)

Jan 1983
Decision
46d
Days
Class 1
Risk

K823645 is an FDA 510(k) clearance for the VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR. This device is classified as a Accessories, Wheelchair (Class I - General Controls, product code KNO).

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1983, 46 days after receiving the submission on December 6, 1982.

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

Submission Details

510(k) Number K823645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1982
Decision Date January 21, 1983
Days to Decision 46 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code KNO — Accessories, Wheelchair
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.3910