510(k) Report

FDA applicant

Regenesis Biomedical, Inc.

Scottsdale, AZ4 decisions1997–20231 recall

FDA records 4 decisions for Regenesis Biomedical, Inc. (Scottsdale, AZ) from 1997 to 2023: 4 510(k) clearances. Most are in product codes ILX (Diathermy, Shortwave, For Use Other Than…) and IMJ (Diathermy, Shortwave, For Use In Applying…). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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, physical medicine panel, where it files most

How often FDA has decided Regenesis Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2010: 12013: 12023: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat3decisions
  • IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat1decision

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091791Provant System, Model 4201Regenesis Biomedical, Inc. · 20101cites it

What has FDA decided for it lately?

  • K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc. · 2023
  • K131979Provant Therapy SystemRegenesis Biomedical, Inc. · 2013
  • K091791Provant System, Model 4201Regenesis Biomedical, Inc. · 2010
  • K972093Regenesis Model 42Regenesis Biomedical, Inc. · 19971 recall

All 4 as Regenesis Biomedical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K972093Regenesis Biomedical PROVANT Wound Therapy System, Model 4201 - The Provant Wound…Sep 29, 2008