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]

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]

Print this page

VIEW MORE SPECIALS

HOTHOUSE
FAR INFRARED DOME

HotHouse

Regular HotHouse
or Grande HotHouse
$699 or $799!

FREE
FIR LUMBAR CUSHION!

Includes Audio CD and
Extensions.

Add Reg HH to Cart

Add Grande HH to Cart

Chi Machine and HotHouse

Chi Machine and
Regular or Grande HotHouse
$1,049 or $1,149!

FREE
FIR LUMBAR CUSHION!

Includes Audio CD and
Extensions.

Add Reg HH + Chi to Cart

Add Grande HH + Chi to Cart

SHOP ONLINE

14 Day Free 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 FULL Refund!

Warranty & 14 Day Trial.

FREE DVD & TESTIMONIAL BOOK WITH PURCHASE!

Shop Our Other Stores

Australia

Canada Flag
Canada

USA
USA

The statements on this website have not been evaluated by the Food and Drug Administration.

The products and services on this website are not intended to diagnose, treat, cure, or prevent any disease.

As always, one should consult with their own health care professional

when considering any dietary supplement, or alternative wellness product or service.

Suggestions for dietary supplements are to nutritionally support or aid a body system or organ.

They are not meant to treat or diagnose a disease.

Some of the material contained in this website was obtained through HTE Americas, Inc.

We are independent distributors for HTE Americas, Inc and Nature's Sunshine Products located in Indiana.

Reproduction in whole or in part without permission is prohibited.