510(k) Report

FDA applicant

Biowave Corporation

Norwalk, CT8 decisions2005–20260 recalls

FDA records 8 decisions for Biowave Corporation (Norwalk, CT) from 2005 to 2026: 8 510(k) clearances. Most are in product codes GZJ (Stimulator, Nerve, Transcutaneous, For Pain…) and GXY (Electrode, Cutaneous). Since 2016 its 510(k)s took a median of 30 days from receipt to decision, against 195 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Biowave Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2021

2008: 12015: 12018: 12021: 22026 (partial year): 1
2007high 2 (2021) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Biowave Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biowave Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief4decisions
  • GXYElectrode, Cutaneous2decisions
  • LIHInterferential Current Therapy1decision
  • NHIStimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 30 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 195 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 10 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 13 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K052289Deepwave Neuromodulation Pain Therapy DeviceBiowave Corporation · 20053cite it
  • K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 20063cite it
  • K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 20082cite it
  • K203158BioWave BioWrapsBiowave Corporation · 20212cite it
  • K152437BiowaveHOME Neuromodulation Pain Therapy DeviceBiowave Corporation · 20152cite it
  • K180943BioWaveGOBiowave Corporation · 20181cites it

What has FDA decided for it lately?

  • K261522BioWave BioWrapsBiowave Corporation · 2026
  • K203158BioWave BioWrapsBiowave Corporation · 2021
  • K210202BioWaveGO RXBiowave Corporation · 2021
  • K180943BioWaveGOBiowave Corporation · 2018
  • K152437BiowaveHOME Neuromodulation Pain Therapy DeviceBiowave Corporation · 2015
  • K072123Homewave Neuromodulations Pain Therapy DeviceBiowave Corporation · 2008
  • K061166Deepwave Percutaneous Neuromodulation Pain Therapy SystemBiowave Corporation · 2006
  • K052289Deepwave Neuromodulation Pain Therapy DeviceBiowave Corporation · 2005

All 8 as Biowave Corporation →