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510(k) Data Aggregation
K Number
K101267Device Name
PREMIO 10 MOXA
Manufacturer
SEDATELEC
Date Cleared
2010-12-03
(212 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
SEDATELEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating. The PREMIO 10 moxa is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
Device Description
The PREMIO 10 moxa is a non-invasive infrared lamp intended to provide topical heating.
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K Number
K060392Device Name
ASP TITANIUM
Manufacturer
SEDATELEC
Date Cleared
2006-04-26
(70 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
SEDATELEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The acupuncture needle is a device intended to pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states. The device consists of a solid, titanium needle.
Device Description
The device consists of a solid, titanium needle.
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K Number
K983798Device Name
SEDATELEC ASP ACUPUNCTURE NEEDLES
Manufacturer
SEDATELEC
Date Cleared
1999-08-27
(303 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
SEDATELEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
Device Description
ASP Type needles consists of a short "tack-like" solid stainless steel needle contained in a plastic injector to introduce the needle in the epidermis, to facilitate the delivery of acupuncture treatment. ASP needles are sterile devices for single use only. The "ASP Gold needle" is an "ASP needle" which has been gold plated (an intermediate laver of copper is added between stainless steel and gold). The ASP needles are offered in a single size.
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K Number
K983800Device Name
DN ACUPUNTURE NEEDLES
Manufacturer
SEDATELEC
Date Cleared
1999-08-27
(303 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
SEDATELEC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To pierce the skin in the practice of acupuncture by qualified practitioners as determined by the states.
Device Description
The DN needle consists of a solid stainless steel needle with a copper wire wrapped around the stainless steel needle shaft. The copper wire acts as a handle which facilitates the delivery of acupuncture treatment by making the needles easier to manipulate and place. DN needles are sterile devices for single use only. The needles are made from 302 grade stainless steel meeting ASTM F899-84 standards. No lubricant is used on the needles.
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