Cleared Traditional

K924414 - THE BTE DYNAMIC LIFT

K924414 is the FDA 510(k) clearance for THE BTE DYNAMIC LIFT by Baltimore Therapeutic Equipment Co.. It is a Class 2 Physical Medicine device (product code IKK) cleared through the Traditional 510(k) pathway after a 165-day FDA review.

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

K924414 is an FDA 510(k) clearance for the THE BTE DYNAMIC LIFT. Classified as System, Isokinetic Testing And Evaluation (product code IKK), Class II - Special Controls.

Submitted by Baltimore Therapeutic Equipment Co. (Hanover, US). The FDA issued a Cleared decision on February 12, 1993 after a review of 165 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.1925 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Baltimore Therapeutic Equipment Co. devices

Submission Details

510(k) Number K924414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d slower than avg
Panel avg: 115d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IKK System, Isokinetic Testing And Evaluation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.1925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - IKK System, Isokinetic Testing And Evaluation

Devices cleared under the same product code (IKK) and FDA review panel - the closest regulatory comparables to K924414.
CC RIDER, MODEL ME180
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KIN-COM ASYMMETRICAL BACK SYSTEM
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K875235 · Orthopedic Systems, Inc. · Jan 1988
SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER
K861622 · Orthopedic Systems, Inc. · May 1986