FDA Listing of the HotHouse Far Infrared Dome

fda device listing for the hothouse

Owner Operator and Registered Establishment | Hsin Ten Health & Wealth

fda device listing regulation number

(a)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.

(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 890.9.

Part 890 Physical Registration Number