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Dynamometer, Ac-Powered

Page Type
Product Code
Regulation Medical Specialty
Orthopedic
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
888.1240
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 888.1240 AC-powered dynamometer

§ 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.

[52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019]

Dynamometer, Ac-Powered

Page Type
Product Code
Regulation Medical Specialty
Orthopedic
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
888.1240
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 888.1240 AC-powered dynamometer

§ 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.

[52 FR 33702, Sept. 4, 1987, as amended at 84 FR 71818, Dec. 30, 2019]