Cleared Traditional

THE BTE DYNAMIC LIFT

K924414 · Baltimore Therapeutic Equipment Co. · Physical Medicine
Feb 1993
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K924414 is an FDA 510(k) clearance for the THE BTE DYNAMIC LIFT, a System, Isokinetic Testing And Evaluation (Class II — Special Controls, product code IKK), submitted by Baltimore Therapeutic Equipment Co. (Hanover, US). The FDA issued a Cleared decision on February 12, 1993, 165 days after receiving the submission on August 31, 1992. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.1925.

Submission Details

510(k) Number K924414 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 1992
Decision Date February 12, 1993
Days to Decision 165 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement

Device Classification

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