510(k) · Cleared
ClearedNeurotech Kneehab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Medical Research, Ltd. · IPF Stimulator, Muscle, Powered
Cleared on Mar 4, 2005 as substantially equivalent to K926510 (Staodyne, Inc., 1993) after an 802-day review. Its family tree reaches back 1 generation to 1993. 15 later devices descend from it.
- Decided
- Mar 4, 2005
- Review
- 802 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926510 (1993). 15 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK926510 Staodyn Ems+2Staodyne, Inc. · 1993
- This deviceK024258 Neurotech KneehabBio-Medical Research, Ltd. · 2005
- Descendant · cites it directly · 14 of its ownK083105 Kneehab XP Conductive Garment, Type 411Bio-Medical Research, Ltd. · 2009
- Descendant · 2 generations on · 9 of its ownK110350 Kneehab XPBio-Medical Research, Ltd. · 2011
- Descendant · 3 generations on · 7 of its ownK150413 QB1 System Powered Muscle Stimulator & Transcutaneous Electrical…Cymedica Orthopedics, Inc. · 2015
- Descendant · 4 generations on · 4 of its ownK163067 CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016
- Descendant · 4 generations on · 1 of its ownK212832 TimeWaver FrequencyTimewaver Production GmbH · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K083105Kneehab XP Conductive Garment, Type 411Bio-Medical Research, Ltd. · 2009 · cites it directly14descendants
- K110350Kneehab XPBio-Medical Research, Ltd. · 2011 · 2 generations on9descendants
- K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc. · 2015 · 3 generations on7descendants
- K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016 · 4 generations on4descendants
- K212832TimeWaver FrequencyTimewaver Production GmbH · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926510 | Staodyn Ems+2 | Staodyne, Inc. | 1993 | — |
| 0 (this device) | K024258 | Neurotech Kneehab | Bio-Medical Research, Ltd. | 2005 | — |
| +1 | K083105 | Kneehab XP Conductive Garment, Type 411 | Bio-Medical Research, Ltd. | 2009 | — |
| +2 | K110350 | Kneehab XP | Bio-Medical Research, Ltd. | 2011 | — |
| +3 | K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve… | Cymedica Orthopedics, Inc. | 2015 | — |
| +4 | K163067 | CyMedica e-vive™ System; CY-1000 | Cymedica Orthopedics, Inc. | 2016 | — |
| +4 | K212832 | TimeWaver Frequency | Timewaver Production GmbH | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2024 | 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 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 |
|---|---|---|---|
| * | K926510 | Staodyn Ems+2Summary page 2…a general-purpose stimulator with indications, which include prevention and retardation of muscle atrophy and muscle re-education Staodyn EMS+2 K926510 Manufactured by Staodyn Inc, Longmount,Co, 7 Non clinical Tests Comparisons of elect… | 1993 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083105 | Kneehab XP Conductive Garment, Type 411 | 2009 | 14 |
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?
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Muscle re-education of the quadriceps
Maintaining or increasing range of motion of the knee joint
Prevention or retardation of disuse atrophy in the quadriceps
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024258: Neurotech Kneehab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024258
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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