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510(k) Data Aggregation
K Number
K042564Device Name
HEMOR-RITE CRYOTHERAPHY
Manufacturer
FAMA HOLDINGS INTERNATIONAL CORP
Date Cleared
2005-09-30
(374 days)
Product Code
LKX
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FAMA HOLDINGS INTERNATIONAL CORP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device use is for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying the device to the tissue, the inflammation is reduced. The base section is used for the treatment of external hemorrhoids and the neck/probe section is used for the treatment of internal hemorrhoids. The lubricant is used to ease the introduction of the probe into the rectum.
Device Description
Hemor-Rite Cryotherapy is an anatomically designed device for applying cold therapy (Cryotherapy) directly to the swollen hemorrhoidal veins of external hemorrhoids and the internal hemorrhoids within the rectal cavity. The direct application of cold provides prompt relief of itching, pain, and swelling. In addition, Hemor~Rite Cryotherapy is beneficial for the treatment of anal and perianal fissures due to the vasoconstriction and analgesia properties of the device. Hemor-Rite Cryotherapy has been designed taking the following factors into consideration: human anatomy and the medical concepts for treating the ailment.
Hemor-Rite Cryotherapy is an anatomically designed medical device ergonamicly shaped for application of cold therapy (Cryotherapy) directly to swollen hemorroidal veins of external hemorrhoids and internal hemorthoids within the rectal canal. The direct application of cold provides prompt relief of itching, pain, and swelling. The device consists of a sealed applicator containing a coolant formula. The Hemor~Rite device is placed into the user's freezer until frozen. After the Hemor-Rite Cryotherapy device is frozen, the user inserts the device to te affected hemorrhoidal area. The probe is maintained in the area for 6-8 minutes, until the probe reaches body temperature, or up to a maximum of 10 minutes. The Hemor~Rite Cryotherapy device is a reusable device.
Hemor~Rite is comprised of two pieces of plastic; the crown and the base.
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