ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL— 510(k) K010209

Name: FDA 510(k) clearance K010209
Creator: U.S. Food and Drug Administration
Published: 2001-06-12

Substantially Equivalent

Biomedical Life Systems, Inc.

FDA 510(k) clearance K010209 for ELECTRO-NERVE STIMULATOR TENS, MODEL HE-DIGITAL, Substantially Equivalent on 2001-06-12. Applicant: Biomedical Life Systems, Inc.. Device class: 2.

Clearance details

Applicant: Biomedical Life Systems, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2001-01-23
Decision date: 2001-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vista, CA, US

Download summary PDF View on FDA.gov ↗

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