510(k) · Cleared
ClearedCyMedica e-vive™ System; CY-1000
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 Dec 1, 2016 as substantially equivalent to K150413 (Cymedica Orthopedics, Inc., 2015) after a 29-day review. Its family tree reaches back 6 generations to 2001. 4 later devices descend from it.
- Decided
- Dec 1, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- IPF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K010335 (2001). 19 ancestors in all, the oldest K926510 (1993). 4 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK010335 Slendertone Flex, Model, 512Bio-Medical Research, Ltd. · 2001
- 5 generations backK022855 Slendertone Flex Bottom & Thigh Toning System, Type 511Bio-Medical Research, Ltd. · 2003
- 4 generations backK070142 Slendertone System Abs, Models 390, E10, X10; Slendertone System…Bio-Medical Research Corp. · 2007
- 3 generations backK083105 Kneehab XP Conductive Garment, Type 411Bio-Medical Research, Ltd. · 2009
- 2 generations backK110350 Kneehab XPBio-Medical Research, Ltd. · 2011
- 1 generation backK150413 QB1 System Powered Muscle Stimulator & Transcutaneous Electrical…Cymedica Orthopedics, Inc. · 2015
- This deviceK163067 CyMedica e-vive™ System; CY-1000Cymedica Orthopedics, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK210674 Shoulder PacemakerNcs Lab Srl · 2021
- Descendant · cites it directly · 1 of its ownK210604 Intellihab SystemCymedica Orthopedics, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK220994 Shoulder PacemakerTMNcs Lab Srl · 2022
- Descendant · 2 generations on · 0 of its ownK220738 Motive Knee WrapCymedica Orthopedics, Inc. · 2022
Most influential descendants
Showing 4 of 4 · See all- K210674Shoulder PacemakerNcs Lab Srl · 2021 · cites it directly1descendant
- K210604Intellihab SystemCymedica Orthopedics, Inc. · 2021 · cites it directly1descendant
- K220994Shoulder PacemakerTMNcs Lab Srl · 2022 · 2 generations on0descendants
- K220738Motive Knee WrapCymedica Orthopedics, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K010335 | Slendertone Flex, Model, 512 | Bio-Medical Research, Ltd. | 2001 | — |
| −5 | K022855 | Slendertone Flex Bottom & Thigh Toning System, Type 511 | Bio-Medical Research, Ltd. | 2003 | — |
| −4 | K070142 | Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts… | Bio-Medical Research Corp. | 2007 | — |
| −3 | K083105 | Kneehab XP Conductive Garment, Type 411 | Bio-Medical Research, Ltd. | 2009 | — |
| −2 | K110350 | Kneehab XP | Bio-Medical Research, Ltd. | 2011 | — |
| −1 | K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve… | Cymedica Orthopedics, Inc. | 2015 | — |
| 0 (this device) | K163067 | CyMedica e-vive™ System; CY-1000 | Cymedica Orthopedics, Inc. | 2016 | — |
| +1 | K210674 | Shoulder Pacemaker | Ncs Lab Srl | 2021 | — |
| +1 | K210604 | Intellihab System | Cymedica Orthopedics, Inc. | 2021 | — |
| +2 | K220994 | Shoulder PacemakerTM | Ncs Lab Srl | 2022 | — |
| +2 | 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 |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K150413 | QB1 System Powered Muscle Stimulator & Transcutaneous Electrical Nerve StimulatorSummary page 5…m NMES and TENS devices are reviewed by the Division of Neurological and Physical Medicine Devices (DNPMD). 3- PREDICATE DEVICE Name & 510(k) Number: K150413 QB1 NMES & TENS System CyMedica Orthopedics, Inc. 4-… | 2015 |
What descends from it? (4)
2 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 15 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K210674 (Ncs Lab Srl, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K150413.
How does its category compare?
All IPF devicesIPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 CyMedica e-vive System is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS). Indications for Use: - As an NMES device, indications are for the following conditions: - Relaxation of muscle spasms - Retardation or prevention of disuse atrophy - Increasing local blood circulation - Re-educating muscles - Immediate…
Read the full statement (106 words)
The CyMedica e-vive System is a multifunctional electrotherapy device with two treatment modes that allow for neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).
Indications for Use:
- As an NMES device, indications are for the following conditions:
- Relaxation of muscle spasms
- Retardation or prevention of disuse atrophy
- Increasing local blood circulation
- Re-educating muscles
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
As a TENS device, indications are for the following conditions:
- Symptomatic relief and management of chronic intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163067 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163067: CyMedica e-vive™ System; CY-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163067
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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