510(k) · Cleared
ClearedMotive Knee Wrap
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 May 12, 2022 as substantially equivalent to K210604 (Cymedica Orthopedics, Inc., 2021) and 1 other predicate after a 59-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- May 12, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K010335 (2001). 39 ancestors in all, the oldest K880042 (1988). No later device cites it as a predicate yet.
- Root · 8 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 7 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 6 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 5 generations backK083105 Kneehab XP Conductive Garment, Type 411Bio-Medical Research, Ltd. · 2009
- 4 generations backK110350 Kneehab XPBio-Medical Research, Ltd. · 2011
- 3 generations backK150413 QB1 System Powered Muscle Stimulator & Transcutaneous Electrical…Cymedica Orthopedics, Inc. · 2015
- 2 generations backK163067 CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016
- 1 generation backK210604 Intellihab SystemCymedica Orthopedics, Inc. · 2021
- This deviceK220738 Motive Knee WrapCymedica Orthopedics, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −7 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −6 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −5 | K083105 | Kneehab XP Conductive Garment, Type 411 | Bio-Medical Research, Ltd. | 2009 | — |
| −4 | K110350 | Kneehab XP | Bio-Medical Research, Ltd. | 2011 | — |
| −3 | K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve… | Cymedica Orthopedics, Inc. | 2015 | — |
| −2 | K163067 | CyMedica e-vive™ System; CY-1000 | Cymedica Orthopedics, Inc. | 2016 | — |
| −1 | K210604 | Intellihab System | Cymedica Orthopedics, Inc. | 2021 | — |
| 0 (this device) | K220738 | Motive Knee Wrap | Cymedica Orthopedics, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (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 |
|---|---|---|---|
| * | K210604 | Intellihab SystemSummary page 11…ation of medical devices, the Motive device is substantially equivalent in design principles to the predicate device, CyMedica Orthopedics, Inc. IntelliHab System, K210604, the primary predicate device. The data included in this submission demonstrates design substantial equivalence to the pred… | 2021 |
| * | K192733 | RelieforMe TENS/EMS Device Model UPK-GE01Summary page 11…ere provided to support the Motive device safety for the OTC use. Additionally, a second predicate device is included, RelieforMe TENS/EMS Device Model UPK-GE01 (K192733) as an OTC device. The intended use, design, materials, and functional characteristics of the Motive device and the prim… | 2019 |
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 21 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 39 ancestors has a recall.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Motive™ Knee Wrap device is intended to strengthen the quadriceps muscle using powered muscle stimulation to
provide symptomatic temporary pain relief associated with knee arthritis.
The Motive™ Knee Wrap device is indicated for adults of 22 years of age and older.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220738: Motive Knee Wrap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220738
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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