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Found 12 results
510(k) Data Aggregation
K Number
K080221Device Name
EA STIMULATOR
Manufacturer
HELIO MEDICAL SUPPLIES, INC.
Date Cleared
2008-09-09
(224 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
HELIO MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is designed to be used in the treatment of chronic, acute, and post-surgical pain.
Device Description
EA Stimulator is a battery powered TENS, which is used in the treatment of chronic, acute, and post-surgical pain. The device contains a printed circuit board, independent intensity controlled channels, and Microcurrent-Milliampere Switches. It also has windows, display frequency, pulse width, and time settings. The device has different stimulation frequency modes with different selected waveforms. EA Stimulator uses self adhesive electrodes and has energy saving feature that automatically turns off if the device has no activity for 5 minutes or when a treatment session is completed.
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K Number
K072778Device Name
BRIO ACUPUNCTURE NEEDLES
Manufacturer
HELIO MEDICAL SUPPLIES, INC.
Date Cleared
2007-11-19
(52 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
HELIO MEDICAL SUPPLIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K062448Device Name
LYRA ACUPUNCTURE NEEDLES
Manufacturer
HELIO MEDICAL SUPPLIES, INC.
Date Cleared
2006-09-20
(29 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
HELIO MEDICAL SUPPLIES, INC.
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
Not Found
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K Number
K052723Device Name
SEVEN STAR NEEDLE
Manufacturer
HELIO MEDICAL SUPPLIES, INC.
Date Cleared
2006-01-13
(106 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
HELIO MEDICAL SUPPLIES, INC.
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
Not Found
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K Number
K050295Device Name
PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES
Manufacturer
HELIO MEDICAL SUPPLIES, INC.
Date Cleared
2005-03-25
(46 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
HELIO MEDICAL SUPPLIES, INC.
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
Not Found
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K Number
K043277Device Name
C&G ACUPUNCTURE NEEDLE
Manufacturer
HELIO MEDICAL SUPPLIES, INC.
Date Cleared
2005-02-08
(74 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
HELIO MEDICAL SUPPLIES, INC.
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
Not Found
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K Number
K024207Device Name
VINCO BRAND ACUPUNCTURE NEEDLE
Manufacturer
HELIO MEDICAL SUPPLIES, INC.
Date Cleared
2003-04-14
(115 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
HELIO MEDICAL SUPPLIES, INC.
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
Vinco Brand Acupuncture Needle
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K Number
K012583Device Name
ACUGLIDE BRAND ACUPUNCTURE NEEDLES
Manufacturer
HELIO MEDICAL SUPPLIES, INC.
Date Cleared
2001-12-11
(123 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
HELIO MEDICAL SUPPLIES, INC.
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
Not Found
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K Number
K991507Device Name
KANGNIAN BRAND ACUPUNCTURE NEEDLE
Manufacturer
HELIO MEDICAL SUPPLIES, INC.
Date Cleared
1999-08-27
(120 days)
Product Code
MQX, MOX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
HELIO MEDICAL SUPPLIES, INC.
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
Kangnian Brand Acupuncture Needle
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K Number
K991508Device Name
ACUMASTER BRAND ACUPUNCTURE NEEDLE
Manufacturer
HELIO MEDICAL SUPPLIES, INC.
Date Cleared
1999-08-27
(120 days)
Product Code
MQX
Regulation Number
880.5580Why did this record match?
Applicant Name (Manufacturer) :
HELIO MEDICAL SUPPLIES, INC.
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
Not Found
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