Strength Testing: Isokinetic Testing & Evaluation (Class II Devices)

Published on 22/05/2015 by admin

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Last modified 22/05/2015

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Chapter 7 Strength Testing: Isokinetic Testing & Evaluation (Class II Devices)

This section reviews complications during isokinetic testing. Nine knee (or related) injuries were reported to the FDA from 5/28/97 to 6/25/99 in Maude and from 5/14/96 to 11/26/86 in MDR (also see Exercise equipment for injuries not specifically related to testing).1

Y70-Y82 MEDICAL DEVICES

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Date Device during Testing Event
5/14/96 KIN-COM A patient with an ACL surgery sustained a patella fracture during maximal strength testing. Note: No unit malfunction was noted.
9/05/95 VIDO ACTIVE A 52-year-old female was 7 weeks post-op for a TKR and had received 4 weeks of PT. During testing, the patient felt something snap/move, resulting in extreme swelling and pain. Note: No unit malfunction was noted.
6/16/95

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