510(k) · Cleared
ClearedKneehab XP Conductive Garment, Type 411
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 Jul 24, 2009 as substantially equivalent to K024258 (Bio-Medical Research, Ltd., 2005) and 1 other predicate after a 277-day review. Its family tree reaches back 3 generations to 2001. 14 later devices descend from it.
- Decided
- Jul 24, 2009
- Review
- 277 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K010335 (2001). 6 ancestors in all, the oldest K926510 (1993). 14 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 2 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 1 generation backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- This deviceK083105 Kneehab XP Conductive Garment, Type 411Bio-Medical Research, Ltd. · 2009
- Descendant · cites it directly · 9 of its ownK110350 Kneehab XPBio-Medical Research, Ltd. · 2011
- Descendant · 2 generations on · 7 of its ownK150413 QB1 System Powered Muscle Stimulator & Transcutaneous Electrical…Cymedica Orthopedics, Inc. · 2015
- Descendant · 3 generations on · 4 of its ownK163067 CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK212832 TimeWaver FrequencyTimewaver Production GmbH · 2021
- Descendant · 4 generations on · 1 of its ownK210674 Shoulder PacemakerNcs Lab Srl · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K110350Kneehab XPBio-Medical Research, Ltd. · 2011 · cites it directly9descendants
- K150413QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorCymedica Orthopedics, Inc. · 2015 · 2 generations on7descendants
- K163067CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016 · 3 generations on4descendants
- K212832TimeWaver FrequencyTimewaver Production GmbH · 2021 · 3 generations on1descendant
- K210674Shoulder PacemakerNcs Lab Srl · 2021 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −2 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −1 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| 0 (this device) | K083105 | Kneehab XP Conductive Garment, Type 411 | Bio-Medical Research, Ltd. | 2009 | — |
| +1 | K110350 | Kneehab XP | Bio-Medical Research, Ltd. | 2011 | — |
| +2 | K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve… | Cymedica Orthopedics, Inc. | 2015 | — |
| +3 | K163067 | CyMedica e-vive™ System; CY-1000 | Cymedica Orthopedics, Inc. | 2016 | — |
| +3 | K212832 | TimeWaver Frequency | Timewaver Production GmbH | 2021 | — |
| +4 | K210674 | Shoulder Pacemaker | Ncs Lab Srl | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 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 19.6 · 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? (2)
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 |
|---|---|---|---|
| * | K024258 | Neurotech KneehabSummary page 1…Marketed Device 1. Name: Kneehab, Type 410 Manufacturer: Bio-Medical Research Ltd. 5 10O(k) No: K024258, March 2005 2. Name System Shorts, Type 390, Model E20 Manufacturer: Bio-Medi… | 2005 |
| * | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20Summary page 1…2. Name System Shorts, Type 390, Model E20 Manufacturer: Bio-Medical Research Ltd. 5 10O(k) No: K070 142, March 2007 4. Description of Device The Kneehab XP Conductive Garment is a portable, two-channel transcutatieous electrical m… | 2007 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K110350 (Bio-Medical Research, Ltd., 2011) has gone furthest, with 9 descendants of its own.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Muscle re-education of the quadriceps,
Maintaining or increase range of motion of the knee joint,
Prevention or retardation of disuse atrophy in the quadriceps,
Early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening,
Increasing local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083105 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083105: Kneehab XP Conductive Garment, Type 411.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083105
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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