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Dynamometer, Nonpowered

Page Type
Product Code
Regulation Medical Specialty
Orthopedic
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
888.1250
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 888.1250 Nonpowered dynamometer

§ 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.

Dynamometer, Nonpowered

Page Type
Product Code
Regulation Medical Specialty
Orthopedic
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
888.1250
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 888.1250 Nonpowered dynamometer

§ 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.