Cleared Traditional

K940919 - CHIEF SR (FDA 510(k) Clearance)

Feb 1995
Decision
344d
Days
Class 2
Risk

K940919 is an FDA 510(k) clearance for the CHIEF SR. This device is classified as a Wheelchair, Standup (Class II - Special Controls, product code IPL).

Submitted by Redman, Inc. (Tucson, US). The FDA issued a Cleared decision on February 3, 1995, 344 days after receiving the submission on February 24, 1994.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3900.

Submission Details

510(k) Number K940919 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received February 24, 1994
Decision Date February 03, 1995
Days to Decision 344 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code IPL — Wheelchair, Standup
Device Class Class II - Special Controls
CFR Regulation 21 CFR 890.3900

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