Cleared Traditional

K922603 - TOTAL WORK INTEGRATOR

K922603 is an FDA 510(k) clearance for TOTAL WORK INTEGRATOR, manufactured by Biodan Medical Systems, Ltd.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K922603 · Biodan Medical Systems, Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
17d
Days
Class 2
Risk

K922603 is an FDA 510(k) clearance for the TOTAL WORK INTEGRATOR, MODEL #940-110. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on June 19, 1992 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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 - K922603

510(k) Number K922603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1992
Decision Date June 19, 1992
Days to Decision 17 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ISD Device Classification - Class 2, Special Controls

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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 - ISD Exerciser, Measuring

All 17
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K922603.
UPPER BODY EXERCISER
K926279 · Henley Intl. · May 1994
EXERCISE BICYCLE
K926287 · Henley Intl. · Mar 1994
HYDRA FITNESS MODEL 311 TOTAL POWER
K926314 · Henley Intl. · Mar 1994
MONARK ERGOMETERS
K912227 · Quinton, Inc. · Aug 1991
MEDEX MACHINE
K880032 · Medex, Inc. · Feb 1988
RESUBMITTED EXCALIBUR
K880271 · Quinton, Inc. · Feb 1988