Cleared Traditional

K924441 - U.S. MEDICAL PS-6000 WHEELCHAIR SCALE
(FDA 510(k) Clearance)

Feb 1993
Decision
164d
Days
Class 1
Risk

K924441 is an FDA 510(k) clearance for the U.S. MEDICAL PS-6000 WHEELCHAIR SCALE. This device is classified as a Scale, Platform, Wheelchair (Class I - General Controls, product code INF).

Submitted by U.S. Medical Corp. (Higgaum, US). The FDA issued a Cleared decision on February 12, 1993, 164 days after receiving the submission on September 1, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3940.

Submission Details

510(k) Number K924441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1992
Decision Date February 12, 1993
Days to Decision 164 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code INF — Scale, Platform, Wheelchair
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.3940