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510(k) Data Aggregation
K Number
K081720Device Name
PRECISION TDP, HEAT AND INFRARED LAMPS AND MARVEL AND WONDER LAMPS
Manufacturer
PRIME HERBS CORPORATION
Date Cleared
2009-06-16
(363 days)
Product Code
ILY, CLA
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
PRIME HERBS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp may be used for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Device Description
Description of Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp; Marvel Lamp and Wonder Lamp are used to provide topical heating to the body. The Precision TDP lamp, Precision Heat Lamp, Precision Infrared Lamp, Marvel Lamp and Wonder Lamp are specially engineered using a rare earth ceramic plate. Emission spectrum ranges from 2 to 50 microns. The emission heating plate should be replaced after 1,200 to 1,500 hours of usage. 110 volt power, 250 watts. It includes timer, safety fuses w/o remote control.
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K Number
K061517Device Name
PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES
Manufacturer
PRIME HERBS CORPORATION
Date Cleared
2006-11-22
(174 days)
Product Code
MQX, MOX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
PRIME HERBS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.
Device Description
Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision Acupuncture Needles, Alpha Acupuncture Needles, Fine Point Acupuncture Needles, Chi Acupuncture Needles and Zen Acupuncture Needles are sterile, single use only. The design, material used, sterility and biocompatibility of this acupuncture Needles meet the general specifications and criteria for an single use acupuncture Needles and is effective for the practice of acupuncture.
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