E.W.L. P-TENS/H-WAVE— 510(k) K862121

Name: FDA 510(k) clearance K862121
Creator: U.S. Food and Drug Administration
Published: 1987-06-17

Substantially Equivalent

Electronic Waveform Laboratory, Inc.

FDA 510(k) clearance K862121 for E.W.L. P-TENS/H-WAVE, Substantially Equivalent on 1987-06-17. Applicant: Electronic Waveform Laboratory, Inc.. Device class: 2.

Clearance details

Applicant: Electronic Waveform Laboratory, Inc.
Product code: Code KZM
Device class: Class 2
Regulation: 21 CFR 890.1375
Advisory panel: Physical Medicine
Date received: 1986-06-03
Decision date: 1987-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington Beach, CA, US

Download summary PDF View on FDA.gov ↗

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