510(k) · Cleared
ClearedHigh Tone Power therapy (HiToP) (Model: HiToP PNP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mohammadali Nezakati · IPF Stimulator, Muscle, Powered
Cleared on Jun 2, 2026 as substantially equivalent to K213655 (Hilltek, LLC, 2023) after a 271-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Jun 2, 2026
- Review
- 271 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K001179 (2000). 13 ancestors in all, the oldest K941461 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 5 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- 4 generations backK040729 Solaris D890 Therapy ProbeDynatronics Corp. · 2004
- 3 generations backK043586 Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp. · 2005
- 2 generations backK113017 Sys*Stim 240Mettler Electronics Corp. · 2012
- 1 generation backK213655 HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)Hilltek, LLC · 2023
- This deviceK252816 High Tone Power therapy (HiToP) (Model: HiToP PNP)Mohammadali Nezakati · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −6 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −5 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| −4 | K040729 | Solaris D890 Therapy Probe | Dynatronics Corp. | 2004 | — |
| −3 | K043586 | Laser Sys*Stim 540, Model ME 540 | Mettler Electronics Corp. | 2005 | — |
| −2 | K113017 | Sys*Stim 240 | Mettler Electronics Corp. | 2012 | — |
| −1 | K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) | Hilltek, LLC | 2023 | — |
| 0 (this device) | K252816 | High Tone Power therapy (HiToP) (Model: HiToP PNP) | Mohammadali Nezakati | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 2003 | 2 | 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 IPF? 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 IPF device
- #1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 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 |
|---|---|---|---|
| * | K213655 | HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch)Summary page 5…cate Manufacturer: gbo Medizintechnik AG • Predicate Trade Name: HiToP® (Model: HiToP® 1touch) • Predicate 510(k): K213655 IV. DEVICE DESCRIPTION The High Tone Power therapy (HiToP® PNP) is a non-invasive electrotherapeutic device use… | 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 26 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 13 ancestors has a recall of any class.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · IPF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IPF
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IPF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IPF
8in 2025
MAUDE reports naming product code IPF, 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 | 8 | 143 | 0 | 11 |
| 2008 | 6 | 140 | 1 | 213 |
| 2009 | 7 | 216 | 0 | 150 |
| 2010 | 4 | 121 | 0 | 14 |
| 2011 | 4 | 275 | 1 | 25 |
| 2012 | 4 | 269 | 3 | 16 |
| 2013 | 10 | 180 | 0 | 6 |
| 2014 | 4 | 264 | 0 | 19 |
| 2015 | 3 | 43 | 0 | 11 |
| 2016 | 7 | 113 | 0 | 8 |
| 2017 | 5 | 110 | 0 | 2 |
| 2018 | 5 | 73 | 0 | 3 |
| 2019 | 4 | 133 | 0 | 10 |
| 2020 | 9 | 121 | 0 | 13 |
| 2021 | 15 | 98 | 0 | 3 |
| 2022 | 7 | 108 | 0 | 4 |
| 2023 | 9 | 255 | 1 | 8 |
| 2024 | 7 | 201 | 0 | 5 |
| 2025 | 3 | 257 | 0 | 8 |
| 2026 | 3 | 206 | 0 | — |
What is it indicated for?
HiToP® PNP is intended to be used as:
Powered Muscle Stimulator (EMS):
-Relaxation of muscle spasms
-Increase local blood circulation
-Muscle re-education
-Maintaining or increasing range of motion
Transcutaneous Electrical Nerve Stimulator (TENS):
adjunctive use in adults to provide temporary relief of pain associated with mild to moderate diabetic peripheral neuropathy of the lower extremities.
HiToP® PNP should be applied to normal, healthy, dry, and clean skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252816 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252816: High Tone Power therapy (HiToP) (Model: HiToP PNP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252816
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026