510(k) · Cleared
ClearedPainshield MD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nano Vibronix, Ltd. · PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Cleared on Aug 22, 2008 as substantially equivalent to K970131 (C.L. Mcintosh & Assoc., Inc., 1997) after a 128-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Aug 22, 2008
- Review
- 128 days
- Class
- Class II
- Product code
- PFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K883228 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK883228 Sonicator 720 (Model ME720)Mettler Electronics Corp. · 1988
- 1 generation backK970131 Orthosonics Duo-Son Ultrasound Diathermy DeviceC.L. Mcintosh & Assoc., Inc. · 1997
- This deviceK081075 Painshield MDNano Vibronix, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK221210 PainShield MD PLUSNanovibronix, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K221210PainShield MD PLUSNanovibronix, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K883228 | Sonicator 720 (Model ME720) | Mettler Electronics Corp. | 1988 | — |
| −1 | K970131 | Orthosonics Duo-Son Ultrasound Diathermy Device | C.L. Mcintosh & Assoc., Inc. | 1997 | — |
| 0 (this device) | K081075 | Painshield MD | Nano Vibronix, Ltd. | 2008 | — |
| +1 | K221210 | PainShield MD PLUS | Nanovibronix, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 PFW? 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 PFW device
- #1 K260076 SAM 3.0 Multi-Hour Continuous Ultrasound Devicescore 12.2 · 4 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 |
|---|---|---|---|
| * | K970131 | Orthosonics Duo-Son Ultrasound Diathermy DeviceSummary page 1…inShield'™ MD. Predicate Devices: The PainShield™ MD is substantially equivalent to the Duo-Son Ultrasonic Diathermy Device manufactured by Orthosonics Ltd., subject of k970131. Description of the Device: The PainShield™ MD is an ultrasonic diathermy device used to apply deep heat to tissues in the body… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221210 | PainShield MD PLUS | 2022 | 0 |
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 20 years and passes through 3 companies; a new generation was cleared every 11.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K221210 (Nanovibronix, Inc., 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PFW devicesPFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · PFW
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PFW
Too few PFW 510(k)s in any year since 2007 to give a median.
Recalls per year · PFW
No recall names PFW since 2007.
Adverse event reports per year · PFW
No MAUDE report names PFW 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 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The PainShield™ MD diathermy device is intended to apply ultrasounic energy to
generate deep heat within body tissues for the treatment of selected medical
conditions such as relief of pain, muscle spasms, and joint contractures.
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/K081075 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081075: Painshield MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081075
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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