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510(k) Data Aggregation
K Number
K040317Device Name
IVC SYSTEM
Manufacturer
MARK H. FRIEDMAN
Date Cleared
2004-05-07
(88 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Applicant Name (Manufacturer) :
MARK H. FRIEDMAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. To be used for cooling therapy when applied to the affected body surface during a migraine headache and for the reduction of pain from muscle spasms associated with migraine headaches.
Device Description
IVC™ device
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K Number
K955529Device Name
CRYTRON SYSTEM
Manufacturer
MARK H. FRIEDMAN
Date Cleared
1996-06-10
(189 days)
Product Code
ILO
Regulation Number
890.5720Why did this record match?
Applicant Name (Manufacturer) :
MARK H. FRIEDMAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
to cool a small portion of the body to provide temporary relief of minor aches and pains and muscle spasms or bruises.
Device Description
Cryotron is fabricated by joining two hollow metal or plastic tubes together into a hollow metal tip which is shaped to fit over the maxillary nerve section or other area selected for cold therapy. Ice water driven by a small pump enters the smaller ube and exits the large tube, chilling the metal which is covered by a disposable plastic sheath. The product will be sold non-sterile; prepackaged, presterilized plastic sleeves will be provided with the Cryotron.
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