Cleared Traditional

STRYKER 5050 STRECHAIR

K941738 · Stryker Medical · Physical Medicine
May 1994
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K941738 is an FDA 510(k) clearance for the STRYKER 5050 STRECHAIR, a Chair, With Casters (Class I — General Controls, product code INM), submitted by Stryker Medical (Kalamazoo, US). The FDA issued a Cleared decision on May 6, 1994, 29 days after receiving the submission on April 7, 1994. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number K941738 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1994
Decision Date May 06, 1994
Days to Decision 29 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