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510(k) Data Aggregation
K Number
K123866Device Name
TANYX
Manufacturer
Date Cleared
2013-09-13
(270 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
MEDECELL US, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To be used in adults only for temporary relief of pain associated with sore and aching muscles in the upper extremities (arms), lower extremities (legs), and lower back due to strain from exercise or normal household and work activities.
Device Description
TANYX® is based on TENS medical technology. The product is to reduce or eliminate pain through the emission of controlled and focused electrical signals. It is a disposable device, designed to be sold directly to consumers for the temporary relief of pain. TANYX® adheres to a person's skin and emits either a fixed or modulated electrical signal through a grid of integrated electrodes. It is a product which is characterized as portable, inexpensive, disposable, and (compared to other TENS-based products) easy to handle and operate. No medical supervision is required.
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