Cleared Traditional

K926028 - BENCHES
(FDA 510(k) Clearance)

Mar 1993
Decision
161d
Days
Class 1
Risk

K926028 is an FDA 510(k) clearance for the BENCHES. This device is classified as a Chair, With Casters (Class I - General Controls, product code INM).

Submitted by Theradapt Products, Inc. (Bensenville, US). The FDA issued a Cleared decision on March 24, 1993, 161 days after receiving the submission on October 14, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3100.

Submission Details

510(k) Number K926028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1992
Decision Date March 24, 1993
Days to Decision 161 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