GroundRules
21 CFR 888.1520: Nonpowered goniometer.
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 goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
Collected 2026-08-27T02:24:47Z. Source file · JSON