Cleared Traditional

CYBEX BACK TESTING AND REHABILITATION SYSTEM

K881681 · Cybex · Physical Medicine
Apr 1990
Decision
736d
Days
Class 2
Risk

About This 510(k) Submission

K881681 is an FDA 510(k) clearance for the CYBEX BACK TESTING AND REHABILITATION SYSTEM, a System, Isokinetic Testing And Evaluation (Class II — Special Controls, product code IKK), submitted by Cybex (Ronkonkoma, US). The FDA issued a Cleared decision on April 25, 1990, 736 days after receiving the submission on April 19, 1988. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.1925.

Submission Details

510(k) Number K881681 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1988
Decision Date April 25, 1990
Days to Decision 736 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

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