21 CFR 890.5950 — Unit, Heating, Powered

Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5950

Identification

A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated 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
IRQUnit, Heating, Powered17
LHCWarmer, Irrigation Solution124
Innolitics

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