TX 3 TENS MODIFIED— 510(k) K913532

Name: FDA 510(k) clearance K913532
Creator: U.S. Food and Drug Administration
Published: 1991-11-22

Substantially Equivalent

Globalcare/Bay Medical Corp.

FDA 510(k) clearance K913532 for TX 3 TENS MODIFIED, Substantially Equivalent on 1991-11-22. Applicant: Globalcare/Bay Medical Corp.. Device class: 2.

Clearance details

Applicant: Globalcare/Bay Medical Corp.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1991-08-05
Decision date: 1991-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holyoke, MA, US

Download summary PDF View on FDA.gov ↗

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