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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
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
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]