ULTIMA TENS XL-A1— 510(k) K020846

Substantially Equivalent

Tenscare, Ltd.

FDA 510(k) clearance K020846 for ULTIMA TENS XL-A1, Substantially Equivalent on 2002-05-21. 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: 2002-03-15
Decision date: 2002-05-21
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.