510(k) · Cleared
ClearedOW100S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Softwave/Trt, LLC · PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers
Cleared on Jul 9, 2024 as substantially equivalent to K231710 (Softwave/Trt, LLC, 2023) after a 208-day review. Its family tree reaches back 4 generations to 2017.
- Decided
- Jul 9, 2024
- Review
- 208 days
- Class
- Class II
- Product code
- PZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN160037 (2017). No later device cites it as a predicate yet.
- Root · 4 generations backDEN160037 dermaPACE SystemSanuwave, Inc. · 2017
- 3 generations backK191961 OrthoGoldTissue Regeneration Technologies · 2019
- 2 generations backK200926 OrthoGold 100Tissue Regeneration Technologies, LLC · 2020
- 1 generation backK231710 OW100SSoftwave/Trt, LLC · 2023
- This deviceK233937 OW100SSoftwave/Trt, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PZL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PZL device
- #1 K243279 DOLORCLAST Focused Shock Wavesscore 10.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231710 | OW100SSummary page 4…ection 878.4685 Extracorporeal shock wave device for treatment of chronic wounds. Product Codes: PZL Predicate Device: TRT, OW100S K231710 Device Description The OW100S is a pulsed acoustic wave device. It includes an electrically powered generator to generate a hig… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All PZL devicesPZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PZL
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PZL
Too few PZL 510(k)s in any year since 2007 to give a median.
Recalls per year · PZL
No recall names PZL since 2007.
Adverse event reports per year · PZL
No MAUDE report names PZL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with…
Read the full statement (114 words)
The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring no larger than 16 cm2, which extend through the epidermis, dermis, tendon, or capsule, but without bone exposure. The OW100S is indicated for adult (22 years and older), diabetic patients presenting with diabetic foot ulcers greater than 30 days in duration and is indicated for use in conjunction with standard diabetic ulcer care.
The OW100S is indicated to provide acoustic pressure shockwaves in the treatment of superficial partial thickness second degree burns in adults (22 years or older). The OW100S is indicated for use in conjunction with standard of care burn treatment(s).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233937 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233937: OW100S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233937
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026