510(k) · Cleared
ClearedLifecare Conductive Garments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Everyway Medical Instruments Co.,Ltd · GXY Electrode, Cutaneous
Cleared on Aug 24, 2011 as substantially equivalent to K053214 (Neurotron Medical, 2005) after a 246-day review. Its family tree reaches back 2 generations to 1994. 20 later devices descend from it.
- Decided
- Aug 24, 2011
- Review
- 246 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932299 (1994). 4 ancestors in all. 20 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK932299 Electro-MeshPrizm Medical, Inc. · 1994
- 1 generation backK053214 Theraknit Garment ElectrodeNeurotron Medical · 2005
- This deviceK103719 Lifecare Conductive GarmentsEveryway Medical Instruments Co.,Ltd · 2011
- Descendant · cites it directly · 19 of its ownK123354 Revitive IXActegy, Ltd. · 2013
- Descendant · 2 generations on · 17 of its ownK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
- Descendant · 3 generations on · 11 of its ownK151834 BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · Recalled
- Descendant · 4 generations on · 5 of its ownK210174 BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021
- Descendant · 4 generations on · 4 of its ownK203710 Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K123354Revitive IXActegy, Ltd. · 2013 · cites it directly19descendants
- K143207Revitive IX (OTC)Actegy, Ltd. · 2015 · 2 generations on17descendants
- K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · 3 generations on11descendants
- K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021 · 4 generations on5descendants
- K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG · 2021 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932299 | Electro-Mesh | Prizm Medical, Inc. | 1994 | — |
| −1 | K053214 | Theraknit Garment Electrode | Neurotron Medical | 2005 | — |
| 0 (this device) | K103719 | Lifecare Conductive Garments | Everyway Medical Instruments Co.,Ltd | 2011 | — |
| +1 | K123354 | Revitive IX | Actegy, Ltd. | 2013 | — |
| +2 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| +3 | K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 | 1 |
| +4 | K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2021 | — |
| +4 | K203710 | Storz Medical MAGNETOLITH Muscle Stimulator | Storz Medical AG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 GXY? 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 GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 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 |
|---|---|---|---|
| * | K053214 | Theraknit Garment ElectrodeSummary page 1…taneous electrode 115-Substantial Equivalency is claimed against the following device: * TheraKnit Garment Cutaneous Electrodes from Neurotron Medical, Inc. 510k# K053214 16-Description of the Device: The single-patient reusable and non-sterile Lifecare HC-88 Series Conductive Garments are cuta… | 2005 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123354 | Revitive IX | 2013 | 19 |
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 17 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K123354 (Actegy, Ltd., 2013) has gone furthest, with 19 descendants of its own.
- 5 other devices also cite its predicate K053214.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, 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 | 7 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
The Lifecare HC-88 Series Conductive Garments are cutaneous electrodes to be used with
legally marketed electrical stimulators (such as powered muscle stimulators and
transcutaneous electrical nerve stimulators).
The knitted garment electrodes will deliver the stimulation signals generated by the stimulator
to the body surface with which they are in contact.
These body parts include hands (gloves), feet (socks), wrists / elbows (wristlets / elbow
guards) and knees (kneecaps).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103719: Lifecare Conductive Garments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103719
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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