H-WAVE— 510(k) K112485

Substantially Equivalent

Electronic Waveform Lab, Inc.

FDA 510(k) clearance K112485 for H-WAVE, Substantially Equivalent on 2011-12-06. Applicant: Electronic Waveform Lab, Inc.. Device class: 2.

Clearance details

Applicant: Electronic Waveform Lab, Inc.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2011-08-29
Decision date: 2011-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington Beach, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GZJ

K252712 — STIMPOD NMS460 Nerve Stimulator2026-05-28
K252767 — actiTENS mini2026-01-16
K252236 — CP Relief Wand Rx - TENS/NMES2025-08-15
K232441 — Unipro (K-UNIPRO-US)2024-08-30
K241228 — TENSWave2024-08-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.