Chi Machine Sun Ancon HotHouse Far Infrared Dome Energy Wellness Products
Espanol

FDA Approval of the HotHouse Far Infrared Dome


New Search Back To Search Results
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

 

New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2009]
[CITE: 21CFR890.5950]
See Related Information on 890.5950 in CDRH databases



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]





VIEW CURRENT SPECIALS

Regular or Grande HotHouse FIR Dome

FIR Far Infrared Portable Sauna Dome

$799.00 and $899.00
with Total Health Formula!

Add Regular HotHouse to Cart
Add Grande HotHouse to Cart
Includes Audio CD and Extensions

Chi Machine and
Reg or Grande HotHouse

Chi Machine and HotHouse Combo

Mix and Match Special
$1,128.00 and $1,228.00!

Add Chi and Reg HH to Cart
Add Chi and Grande HH to Cart
Includes Audio CD and Extensions.

 FREE DVD and TESTIMONIAL BOOK WITH PURCHASE!

Warranty and 14 Day Trial.

The 14 day trial period
starts when you
receive the product.

If you are not
100% satisfied,
you may return the product for a FULLRefund.

Outside the USA
Shop our Other Stores

Australia and Europe

Canada