21 CFR 890.5940 — Unit, Chilling

Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5940

Identification

A chilling unit is a refrigerative device intended for medical purposes to chill and maintain cold packs at a reduced temperature.

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

Product Codes

Product CodeDevice NameClassDevicesAttributes
IMFUnit, Chilling12
Innolitics

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