Cleared Traditional

K870298 - REDMAN ACCESSORIES
(FDA 510(k) Clearance)

Feb 1987
Decision
29d
Days
Class 1
Risk

K870298 is an FDA 510(k) clearance for the REDMAN ACCESSORIES. This device is classified as a Accessories, Wheelchair (Class I - General Controls, product code KNO).

Submitted by Redman, Inc. (Bloomington, US). The FDA issued a Cleared decision on February 26, 1987, 29 days after receiving the submission on January 28, 1987.

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

Submission Details

510(k) Number K870298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date February 26, 1987
Days to Decision 29 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