804SIII; 804W; LIBRA TENS; 410; S-TENS II— 510(k) K021846

Name: FDA 510(k) clearance K021846
Creator: U.S. Food and Drug Administration
Published: 2002-11-22

Substantially Equivalent

Body Clock Health Care, Ltd.

FDA 510(k) clearance K021846 for 804SIII; 804W; LIBRA TENS; 410; S-TENS II, Substantially Equivalent on 2002-11-22. Applicant: Body Clock Health Care, Ltd.. Device class: 2.

Clearance details

Applicant: Body Clock Health Care, Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2002-06-05
Decision date: 2002-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: London, England, GB

Download summary PDF View on FDA.gov ↗

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