FACTS HAND AND PINCH GRIP COMBO

• K Number: K073154
• Device Name: FACTS HAND AND PINCH GRIP COMBO
• Manufacturer: GLOBAL SERVICES GROUP, LLC
• Date Cleared: 2008-02-14 ( 98 days)
• Product Code: LBB
• Regulation Number: 888.1240
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: N/A

Intended Use

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Device Description

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AI/ML Overview

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Regulation Number and Section

§ 888.1240 AC-powered dynamometer.

(a)
Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.