GroundRules
21 CFR 888.1250: Nonpowered dynamometer.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 888—ORTHOPEDIC DEVICES
- Subpart B—Diagnostic Devices
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON