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FDA Device Listing - Sun Ancon Chi Machine

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Proprietary Name: Advanced Electro Reflex Energizer; SOQI; THE CHI MACHINE
Classification Name: MASSAGER, THERAPEUTIC, ELECTRIC
Product Code: ISA
Device Class: 1
Regulation Number: 890.5660
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

FDA Approval - Sun Ancon Chi Machine

 
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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2009]
[CITE: 21CFR890.5660]
See Related Information on 890.5660 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. 890.5660 Therapeutic massager.

(a)Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.

(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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