Cleared Traditional

K922772 - TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR

K922772 is an FDA 510(k) clearance for TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR, manufactured by Biodan Medical Systems, Ltd.. The device is a Class 2 Physical Medicine device with product code IKK cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K922772 · Biodan Medical Systems, Ltd. · Physical Medicine device
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Jul 1992
Decision
34d
Days
Class 2
Risk

K922772 is an FDA 510(k) clearance for the TWO POSITION ROLL-UP BACK ATTACHMENT CHAIR. Classified as System, Isokinetic Testing And Evaluation (product code IKK), Class II - Special Controls.

Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on July 13, 1992 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biodan Medical Systems, Ltd. devices

FDA 510(k) Submission Details - K922772

510(k) Number K922772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1992
Decision Date July 13, 1992
Days to Decision 34 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
81d faster than avg
Panel avg: 115d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKK Device Classification - Class 2, Special Controls

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 K922772.
CC RIDER, MODEL ME180
K951916 · Mettler Electronics Corp. · Oct 1995
KIN-COM ASYMMETRICAL BACK SYSTEM
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ISOKINETIC SYSTEM, TESTING AND EVALUATION
K875235 · Orthopedic Systems, Inc. · Jan 1988
SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER
K861622 · Orthopedic Systems, Inc. · May 1986