FDA Approval of the HotHouse Far Infrared Dome

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FDA Approval of the HotHouse Far Infrared Dome

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Proprietary Name:	HOTHOUSE
Classification Name:	UNIT, HEATING, POWERED
Product Code:	IRQ
Device Class:	1
Regulation Number:	890.5950
Medical Specialty:	Physical Medicine
Registered Establishment Name:	HSIN TEN HEALTH & WEALTH INDUSTRY (HEFEI) CO., LTD
Registered Establishment Number:	3005517782
Owner/Operator:	HSIN TEN HEALTH & WEALTH INDUSTRY (HEFEI) CO., LTD
Owner/Operator Number:	9041877
Establishment Operations:	Manufacturer

Help | More About 21CFR

[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2009]

[CITE: 21CFR890.5950]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H--MEDICAL DEVICES

PART 890 -- PHYSICAL MEDICINE DEVICES

Subpart F--Physical Medicine Therapeutic Devices

Sec. 890.5950 Powered heating unit.

(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.

[48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001]

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