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K Number
K970870
Device Name
DIGIT-GRIP WITH LCD (DGR002)
Manufacturer
NK BIOTECHNICAL CORP.
Date Cleared
1997-05-02

(53 days)

Product Code
HRW
Regulation Number
888.1250
Type
Traditional
Panel
NE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 888.1250 Nonpowered dynamometer.

(a)
Identification. A nonpowered dynamometer is a mechanical device intended for medical purposes to measure the pinch and grip muscle strength of a patient's hand.(b)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807.