FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

FDA 510(k) Search

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

Intended Use

Device Description

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

N/A

Reference Devices

N/A

AI/ML (Artificial Intelligence / Machine Learning)

N/A

Therapeutic

N/A

Diagnostic

N/A

SaMD (Software as a Medical Device)

N/A

IVD (In Vitro Diagnostic)

N/A

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

Regulation Number and Section

§ 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.

Summary

N/A