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- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
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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
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
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.