Cleared Traditional

SHOWER CHAIRS

K922045 · Medical Device Inspection Co., Inc. · Physical Medicine
May 1992
Decision
25d
Days
Class 1
Risk

About This 510(k) Submission

K922045 is an FDA 510(k) clearance for the SHOWER CHAIRS, a Chair, With Casters (Class I — General Controls, product code INM), submitted by Medical Device Inspection Co., Inc. (Great Neck, US). The FDA issued a Cleared decision on May 26, 1992, 25 days after receiving the submission on May 1, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number K922045 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1992
Decision Date May 26, 1992
Days to Decision 25 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

Product Code INM — Chair, With Casters
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3100