Cleared Traditional

K922092 - SINGLE CHAIR INTEGRAL BACK ATTACHMENT
(FDA 510(k) Clearance)

K922092 · Biodan Medical Systems, Ltd. · Physical Medicine
May 1992
Decision
21d
Days
Class 2
Risk

K922092 is an FDA 510(k) clearance for the SINGLE CHAIR INTEGRAL BACK ATTACHMENT. This device is classified as a System, Isokinetic Testing And Evaluation (Class II — Special Controls, product code IKK).

Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on May 26, 1992, 21 days after receiving the submission on May 5, 1992.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.1925.

Submission Details

510(k) Number K922092 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1992
Decision Date May 26, 1992
Days to Decision 21 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IKK — System, Isokinetic Testing And Evaluation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.1925