510(k) · Cleared
ClearedPainShield MD PLUS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanovibronix, Inc. · PFW Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Cleared on Nov 23, 2022 as substantially equivalent to K081075 (Nano Vibronix, Ltd., 2008) after a 210-day review. Its family tree reaches back 3 generations to 1988.
- Decided
- Nov 23, 2022
- Review
- 210 days
- Class
- Class II
- Product code
- PFW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883228 (1988). No later device cites it as a predicate yet.
- Root · 3 generations backK883228 Sonicator 720 (Model ME720)Mettler Electronics Corp. · 1988
- 2 generations backK970131 Orthosonics Duo-Son Ultrasound Diathermy DeviceC.L. Mcintosh & Assoc., Inc. · 1997
- 1 generation backK081075 Painshield MDNano Vibronix, Ltd. · 2008
- This deviceK221210 PainShield MD PLUSNanovibronix, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883228 | Sonicator 720 (Model ME720) | Mettler Electronics Corp. | 1988 | — |
| −2 | K970131 | Orthosonics Duo-Son Ultrasound Diathermy Device | C.L. Mcintosh & Assoc., Inc. | 1997 | — |
| −1 | K081075 | Painshield MD | Nano Vibronix, Ltd. | 2008 | — |
| 0 (this device) | K221210 | PainShield MD PLUS | Nanovibronix, Inc. | 2022 | — |
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 12.1 · 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 |
|---|---|---|---|
| * | K081075 | Painshield MDSummary page 4…Regulation Number: 21 CFR 890.5300 Predicate Device: Manufacturer: NanoVibronix, Inc. Trade Name: PainShield MD 510(k) Number: K081075 Product Code: PFW Device Classification: Class II Regulation Number: 21 CFR 890.5300… | 2008 |
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 34 years and passes through 4 companies; a new generation was cleared every 11.2 years on median.
- None of the 3 ancestors has a recall.
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. 2022, 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 PLUS is intended to apply ultrasonic 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 as stated in the FDA summary.
https://510kreport.com/device/K221210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221210: PainShield MD PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221210
Report an extraction error
Are you the manufacturer?
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