MODEL HS-2 TENS DEVICE— 510(k) K962951

Name: FDA 510(k) clearance K962951
Creator: U.S. Food and Drug Administration
Published: 1997-08-06

Substantially Equivalent

Technalithics Laboratories, Inc.

FDA 510(k) clearance K962951 for MODEL HS-2 TENS DEVICE, Substantially Equivalent on 1997-08-06. Applicant: Technalithics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Technalithics Laboratories, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 1996-07-26
Decision date: 1997-08-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waco, TX, US

Download summary PDF View on FDA.gov ↗

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