TENS CARE, MODEL XL-Y3— 510(k) K011543

Substantially Equivalent

Tenscare, Ltd.

FDA 510(k) clearance K011543 for TENS CARE, MODEL XL-Y3, Substantially Equivalent on 2001-08-31. Applicant: Tenscare, Ltd.. Device class: 2.

Clearance details

Applicant: Tenscare, Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2001-05-18
Decision date: 2001-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Timperley, Cheshire, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.