21 CFR 890.3520 — Plinth

Physical Medicine (PM) · Part 890 Subpart D—Physical Medicine Prosthetic Devices · § 890.3520

Identification

A plinth is a flat, padded board with legs that is intended for medical purposes. A patient is placed on the device for treatment or examination.

Classification Rationale

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 § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Product Codes