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510(k) Data Aggregation
K Number
K962951Device Name
MODEL HS-2 TENS DEVICE
Manufacturer
Date Cleared
1997-08-06
(376 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
TECHNALITHICS LABORATORIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sportstim 2.0 can only be used upon the prescription of a physician for the symptomatic relief of chronic intractable pain, including the relief of post-traumatic and post-surgical pain.
Device Description
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