510(k) Report

FDA applicant

Innovative Health Solutions (Ihs), Inc.

Versailles, IN2 decisions2017–20190 recalls

FDA records 2 decisions for Innovative Health Solutions (Ihs), Inc. (Versailles, IN) from 2017 to 2019: 2 De Novo grants. Most are in product codes PZR (Percutaneous Nerve Stimulator For Opioid…) and QHH (Non-Implanted Nerve Stimulator For Pain…). 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 Innovative Health Solutions (Ihs), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2017: 12019: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Innovative Health Solutions (Ihs), Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PZRPercutaneous Nerve Stimulator For Opioid Withdrawal1decision
  • QHHNon-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)1decision

Who builds on its devices?

Later devices cite its devices 5 times; 0 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.

  • DEN180057IB-StimInnovative Health Solutions (Ihs), Inc. · 20193cite it
  • DEN170018NSS-2 SystemInnovative Health Solutions (Ihs), Inc. · 20172cite it

What has FDA decided for it lately?

  • DEN180057IB-StimInnovative Health Solutions (Ihs), Inc. · 2019
  • DEN170018NSS-2 SystemInnovative Health Solutions (Ihs), Inc. · 2017

All 2 as Innovative Health Solutions (Ihs), Inc. →