Electrode, Cutaneous
Regulation 882.1320
12510(k)s in 12 months (441 all time)
0recalls in 12 months (20 all time)
19recalls that name a 510(k)
Top companies in GXY
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 31, 2023 | Coapt LLC Coapt ControlSeal Electrode, cutaneous EMG Electrode Open, Classified |
GXY | K223605 |
| Oct 31, 2023 | Coapt LLC Coapt Dome Electrode, Gen2 system, cutaneous electrode Open, Classified |
GXY | K190416 |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable
Model Number: 302288-000 Open, Classified |
GXY | K933803 |
| Mar 14, 2022 | Neuralynx Inc ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Signific Open, Classified |
GXY | None listed |
| May 9, 2014 | Medtronic Navigation, Inc. MOUSE 9732721 STERILE O-ARM 10PK Terminated |
GXY | K001284 K012937 +4 |
| May 9, 2014 | Medtronic Navigation, Inc. DRAPE 9732722 TUBE STERILE O-ARM 20PK Terminated |
GXY | K001284 K012937 +4 |
| Feb 14, 2013 | NAImco Inc dba Richmar Inc Foam electrodes with Silver-Carbon construction:
P/N 202-9271, Cat No. 400-898, 2" x 2" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010
P/N 202-9281, Ca Terminated |
GXY | K050469 |
| Feb 14, 2013 | NAImco Inc dba Richmar Inc Foam Electrodes with Carbon construction:
P/N 201-1261, Cat Nos.: 201-126, 203-678, and 400-856, 1.5" x 3.5" Electrode, Foam, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 Terminated |
GXY | K050469 |
| Feb 14, 2013 | NAImco Inc dba Richmar Inc Cloth electrodes with Silver-Carbon construction:
P/N 202-9231, Cat No. 400-899, 2" x 2" Electrode, Cloth, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010
P/N 202-9241, Terminated |
GXY | K050469 |
| Feb 14, 2013 | NAImco Inc dba Richmar Inc Cloth electrodes with Carbon construction:
P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Se Terminated |
GXY | K050469 |
| Dec 10, 2012 | Covidien LLC dba Uni-Patch Empi STIMC RE Self Adhesive electrodes. For use on TENS, NMES, FES. a DJO brand
A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological s Terminated |
GXY | K902195 |
| Dec 10, 2012 | Covidien LLC dba Uni-Patch Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes,
A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e Terminated |
GXY | K915333 |
| Dec 10, 2012 | Covidien LLC dba Uni-Patch Reusable, Self-Adhering TENS/NMES/FES electrodes Single Patient Use Only.
An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the ele Terminated |
GXY | K900519 |
| Dec 10, 2012 | Covidien LLC dba Uni-Patch Reusable, non-sterile, self-adhering electrodes for use with TENS/NMES, . Made in the U.S.A. Cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiol Terminated |
GXY | K901575 |
| Jan 26, 2012 | Nellcor Puritan Bennett Inc. (dba Covidien LP) BIS Bilateral Sensors, part number 186-0212, packaged in boxes of 10. For use with BIS Monitoring System, Labeled as either Covidien Llc, or Aspect Medical Systems, Inc.
Product Usage:
To enable rec Terminated |
GXY | K062692 |
| Aug 1, 2011 | Axiobionics, LLC AxioBionics Wearable Therapy BioVest/Unitard that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5".
Terminated |
GXY | K944543 |
| Aug 1, 2011 | Axiobionics, LLC AxioBionics Wearable Therapy BioShorts that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5".
Cutane Terminated |
GXY | K944543 |
| Aug 1, 2011 | Axiobionics, LLC AxioBionics Wearable TherapyFreeStep Sleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6" Terminated |
GXY | K944543 |
| Aug 1, 2011 | Axiobionics, LLC AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x Terminated |
GXY | K944543 |
| May 17, 2010 | International Rehabilitative Sciences, Inc. The "RS-FBG Full Back Conductive Garment" with electrode attachments for use with interferential and muscle stimulation with a Transcutaneous Electrical Nerve Stimulation device (TENS) and/or muscle s Terminated |
GXY | K090951 |
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