510(k) · Cleared
ClearedActiPatch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioelectronics Corporation · PQY Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain
Cleared on Jan 31, 2020 as substantially equivalent to K152432 (Bioelectronics Corporation, 2017) after a 165-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jan 31, 2020
- Review
- 165 days
- Class
- Class II
- Product code
- PQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K903675 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK903675 Magnetic Resonance Therapy DeviceMrt, Inc. · 1991
- 3 generations backK070541 Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIIvivi Technologies, Inc. · 2008
- 2 generations backK092044 Orthocor Knee System, Median, Large, X-LargeOrthocor Medical · 2009
- 1 generation backK152432 ActiPatch (R)Bioelectronics Corporation · 2017
- This deviceK192234 ActiPatchBioelectronics Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903675 | Magnetic Resonance Therapy Device | Mrt, Inc. | 1991 | — |
| −3 | K070541 | Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II | Ivivi Technologies, Inc. | 2008 | — |
| −2 | K092044 | Orthocor Knee System, Median, Large, X-Large | Orthocor Medical | 2009 | — |
| −1 | K152432 | ActiPatch (R) | Bioelectronics Corporation | 2017 | — |
| 0 (this device) | K192234 | ActiPatch | Bioelectronics Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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 PQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K152432 | ActiPatch (R)Summary page 4…rapy 6. Product Classification: 21 CFR 890.5290 (b) Product Code: PQY 7. Predicate Devices: Primary Predicate: ActiPatch (K152432) 8. Description of Device: The ActiPatch® device is a pulsed shortwave therapy… | 2017 |
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 29 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All PQY devicesPQY Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · PQY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · PQY
Too few PQY 510(k)s in any year since 2007 to give a median.
Recalls per year · PQY
No recall names PQY since 2007.
Adverse event reports per year · PQY
1in 2025
MAUDE reports naming product code PQY, not matched to any one device; reports are not rates.
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 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Adjunctive treatment of musculoskeletal pain
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192234 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192234: ActiPatch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192234
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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