TENSCARE, MODEL TENS XL-2— 510(k) K003591

Substantially Equivalent

Tenscare, Ltd.

FDA 510(k) clearance K003591 for TENSCARE, MODEL TENS XL-2, Substantially Equivalent on 2001-02-14. 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: 2000-11-21
Decision date: 2001-02-14
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.