LAFAYETTE INSTRUMENT COMPANY, INC.

Address:3700 Sagamore Pkwy N,La Fayette,IN,47904,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Goniometer, Ac-Powered (KQX) (1)

Premarket Exempt

Yes

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Lafayette Hand-Held Dynamometer - 00855170007379 Catalog Number : 01165A

Device Description : The Lafayette Hand-Held Dynamometer is an ergonomic hand-held device for objecti The Lafayette Hand-Held Dynamometer is an ergonomic hand-held device for objectively quantifying muscle strength. The device comes in an ergonomic plastic housing that fits comfortably in the palm of the hand. An elastic strap helps keep the HHD in place. The device has a LCD screen for data readout and menus for setup. The patient pushes on a stirrup accessory which is attached to the shaft of a force measuring load cell. The load cell senses the amount of force being applied to the device by the patient and this load is displayed in the LCD in pounds, kilograms or newtons. An optional test stand accessory and holder are used to position the HHD for the test.

Device Class : 1

Duns Number: 005080650

Premarket Exempt : Yes

Product Code : KQX

Prescription Use : No

Device Count : 1

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