SMART-TENS, MODEL 456— 510(k) K961376

Name: FDA 510(k) clearance K961376
Creator: U.S. Food and Drug Administration
Published: 1996-09-12

Substantially Equivalent

Bio-Medical Research, Ltd.

FDA 510(k) clearance K961376 for SMART-TENS, MODEL 456, Substantially Equivalent on 1996-09-12. Applicant: Bio-Medical Research, Ltd.. Device class: 2.

Clearance details

Applicant: Bio-Medical Research, Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1996-04-08
Decision date: 1996-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laurel, MD, US

Download summary PDF View on FDA.gov ↗

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