510(k) Applications & Approvals – Electronic Waveform Inc. (Multiple K Numbers)

510(k) Applications & Approvals – Electronic Waveform Inc. (Multiple K Numbers)

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510(K) Number: K813601
Device Name: E.W.L. P-TENS MODEL(TENS
Manufacturer: ELECTRONIC WAVEFORM LABORATORY, INC.
Device Classification Name: Stimulator, Nerve, Transcutaneous, For Pain Relief
Regulation Number: 882.5890
Classification Product Code: GZJ
Date Received: 12/28/1981
Decision Date: 03/19/1982
Regulation Medical Specialty: Neurology
Request Contents: All 510(k) applications and approvals, and related correspondence for Electronic Waveform Inc., including but not limited to: K813601, K862121, K873604, K915230, K081998, K103738, K112485.
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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