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510(k) Data Aggregation
K Number
K003591Device Name
TENSCARE, MODEL TENS XL-2Manufacturer
Date Cleared
2001-02-14
(85 days)
Product Code
Regulation Number
882.5890Type
TraditionalPanel
NeurologyReference & Predicate Devices
N/A
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Device Name :
TENSCARE, MODEL TENS XL-2
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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