510(k) · Cleared
ClearedIntellihab System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cymedica Orthopedics, Inc. · IPF Stimulator, Muscle, Powered
Cleared on Jun 3, 2021 as substantially equivalent to K163067 (Cymedica Orthopedics, Inc., 2016) after a 94-day review. Its family tree reaches back 7 generations to 2001. 1 later device descends from it.
- Decided
- Jun 3, 2021
- Review
- 94 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K010335 (2001). 20 ancestors in all, the oldest K926510 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 6 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 5 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 4 generations backK083105 Kneehab XP Conductive Garment, Type 411Bio-Medical Research, Ltd. · 2009
- 3 generations backK110350 Kneehab XPBio-Medical Research, Ltd. · 2011
- 2 generations backK150413 QB1 System Powered Muscle Stimulator & Transcutaneous Electrical…Cymedica Orthopedics, Inc. · 2015
- 1 generation backK163067 CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016
- This deviceK210604 Intellihab SystemCymedica Orthopedics, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK220738 Motive Knee WrapCymedica Orthopedics, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K220738Motive Knee WrapCymedica Orthopedics, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −6 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −5 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −4 | K083105 | Kneehab XP Conductive Garment, Type 411 | Bio-Medical Research, Ltd. | 2009 | — |
| −3 | K110350 | Kneehab XP | Bio-Medical Research, Ltd. | 2011 | — |
| −2 | K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve… | Cymedica Orthopedics, Inc. | 2015 | — |
| −1 | K163067 | CyMedica e-vive™ System; CY-1000 | Cymedica Orthopedics, Inc. | 2016 | — |
| 0 (this device) | K210604 | Intellihab System | Cymedica Orthopedics, Inc. | 2021 | — |
| +1 | K220738 | Motive Knee Wrap | Cymedica Orthopedics, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
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 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 |
|---|---|---|---|
| * | K163067 | CyMedica e-vive™ System; CY-1000Summary page 13…des, and electrode gel. The biocompatibility of the conductive garment, electrodes, and electrode gel were previously evaluated and cleared under 510(K) submission K163067. The biocompatibility testing had been conducted according to the requirements of ISO 10993: 2009 and tested as a surface cont… | 2016 |
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 |
|---|---|---|---|
| K220738 | Motive Knee Wrap | 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 2.3 years on median.
- None of the 20 ancestors has a recall.
- Of its descendants, K220738 (Cymedica Orthopedics, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K163067.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The Intellihab system is intended to strengthen the quadricep muscle using powered muscle stimulation to provide symptomatic temporary pain relief associated with knee osteoarthritis and improvement of the knee joint mobility when the recommended treatment regimens are followed.
In addition, the Intellihab System is indicated for the following:
• Retardation or prevention of disuse atrophy
• Evaluation of joint mobility by measuring and recording range of motion
The Intellihab System is indicated for adults of 22 years of age and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210604 · printed Nov 3, 2026
Cite this page
510(k) Report. “K210604: Intellihab System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K210604
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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