21 CFR 890.5700 — Pack, Hot Or Cold, Reusable

Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5700

Identification

A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807. The device also is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Product Codes