510(k) · Cleared
ClearedTheraknit Garment Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurotron Medical · GXY Electrode, Cutaneous
Cleared on Dec 20, 2005 as substantially equivalent to K932299 (Prizm Medical, Inc., 1994) and 2 other predicates after a 33-day review. Its family tree reaches back 1 generation to 1994. 29 later devices descend from it.
- Decided
- Dec 20, 2005
- Review
- 33 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K932299 (1994). 3 ancestors in all. 29 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK932299 Electro-MeshPrizm Medical, Inc. · 1994
- This deviceK053214 Theraknit Garment ElectrodeNeurotron Medical · 2005
- Descendant · cites it directly · 20 of its ownK103719 Lifecare Conductive GarmentsEveryway Medical Instruments Co.,Ltd · 2011
- Descendant · 2 generations on · 19 of its ownK123354 Revitive IXActegy, Ltd. · 2013
- Descendant · 3 generations on · 17 of its ownK143207 Revitive IX (OTC)Actegy, Ltd. · 2015
- Descendant · 4 generations on · 11 of its ownK151834 BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · Recalled
- Descendant · 5 generations on · 5 of its ownK210174 BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K103719Lifecare Conductive GarmentsEveryway Medical Instruments Co.,Ltd · 2011 · cites it directly20descendants
- K123354Revitive IXActegy, Ltd. · 2013 · 2 generations on19descendants
- K143207Revitive IX (OTC)Actegy, Ltd. · 2015 · 3 generations on17descendants
- K151834BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2017 · 4 generations on11descendants
- K210174BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-SetBemer Int AG · 2021 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932299 | Electro-Mesh | Prizm Medical, Inc. | 1994 | — |
| 0 (this device) | K053214 | Theraknit Garment Electrode | Neurotron Medical | 2005 | — |
| +1 | K103719 | Lifecare Conductive Garments | Everyway Medical Instruments Co.,Ltd | 2011 | — |
| +2 | K123354 | Revitive IX | Actegy, Ltd. | 2013 | — |
| +3 | K143207 | Revitive IX (OTC) | Actegy, Ltd. | 2015 | — |
| +4 | K151834 | BEMER Classic Set, BEMER Pro-Set | Bemer Int AG | 2017 | 1 |
| +5 | K210174 | BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set | Bemer Int 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K932299 | Electro-MeshSummary page 1…800-367-1238 Contact: Jack Guldalian, President Prepared: August 24, 2005 A. LEGALLY MARKETED PREDICATE DEVICES K932299 Electro-Mesh Glove Electrode Prizm Medical, Inc. K944487 Electro-Mesh Sock, Wrap and Sleeve Electrodes Prizm Medic… | 1994 |
| * | K944487 | Electro-Mesh Sock, Wrap, and Sleeve ElectrodesSummary page 1…ent Prepared: August 24, 2005 A. LEGALLY MARKETED PREDICATE DEVICES K932299 Electro-Mesh Glove Electrode Prizm Medical, Inc. K944487 Electro-Mesh Sock, Wrap and Sleeve Electrodes Prizm Medical, Inc. K943009 SMD Glove, Sock and Sleeve Electrodes Scie… | 1995 |
| * | K943009 | SMD ElectrodesSummary page 1…E DEVICES K932299 Electro-Mesh Glove Electrode Prizm Medical, Inc. K944487 Electro-Mesh Sock, Wrap and Sleeve Electrodes Prizm Medical, Inc. K943009 SMD Glove, Sock and Sleeve Electrodes Scientific Medical Devices, Inc. B. DEVICE DESCRIPTION The TheraKnit Garment… | 1995 |
What descends from it? (29)
See all 296 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103719 | Lifecare Conductive Garments | 2011 | 20 |
| K171721 | Electrodes with silver conductive | 2018 | 5 |
| K171798 | Silverwear Silver Pro Garment Device | 2018 | 3 |
| K200942 | Well-Life Garment Electrodes (GM Series) | 2021 | 0 |
| K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro -… | 2018 | 0 |
| K061343 | Inspirstar Glove Electrode | 2006 | 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?
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TheraKnit Garment Electrodes are cutaneous electrodes to be used with legally marketed TENS stimulating device. 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 can include hand (glove), feet (socks), elbow or knee (sleeve), arm, leg, shoulder, back (pads).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053214: Theraknit Garment Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053214
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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