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510(k) Data Aggregation
K Number
K964397Device Name
THERAPIK
Manufacturer
THE JENEX CORPORATION
Date Cleared
1997-11-04
(365 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
THE JENEX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Therapik is indicated for use to provide temporary relief of the pain and itching resulting from insect stings and bites such as bees, wasps and mosquitoes by increasing localized blood flow.
Device Description
The Therapik is a small, portable, hand-held, battery-powered device equipped with a carrying wrist strap. It measures approximately 3cm x 10cm and weighs less than 4 ounces, including the 9 volt battery. The heat is initiated by use of a simple, non-locking, finger-or thumb-activated on/off switch. Heat is produced by pressing the switch. The Therapik device delivers 50 - 60°C heat directly on the user's skin. The user is instructed to apply the device for as long as the heat is comfortable on the skin (approximately 20 - 30 seconds).
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