| Device Type ID | 3672 |
| Device Name | Electrode, Cutaneous |
| Regulation Description | Cutaneous Electrode. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.1320 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GXY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 3672 |
| Device | Electrode, Cutaneous |
| Product Code | GXY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cutaneous Electrode. |
| CFR Regulation Number | 882.1320 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AXELGAARD MFG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AXELGAARD MFG. CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AXIOBIONICS LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIO PROTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CATHAY INTERNATIONAL, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CERIBELL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COLLEGE PARK INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COVIDIEN | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DAEHAN MEDICAL SYSTEMS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DRTV ASIA LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DYNATRONICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GMDASZ MANUFACTURING CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HIVOX BIOTEK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INCEREB LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INFINITE BIOMEDICAL TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
JIANGSU ZEKANG MEDICAL TECHNOLOGY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LEONHARD LANG GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NATUS MEDICAL INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROMETRIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEUROVIRTUAL USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OTTO BOCK HEALTHCARE, GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS CONSUMER LIFESTYLE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RHYTHMLINK INTERNATIONAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHESTER ELECTRO MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN KONMED TECHNOLOGY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SHENZHEN QUALITY MEDICAL TECHNOLOGY CO.,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZMI ELECTRONICS, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 12 |
Device-Device Incompatibility | 8 |
Device Operates Differently Than Expected | 6 |
Low Readings | 3 |
Compatibility Problem | 3 |
Use Of Device Problem | 3 |
Failure To Advance | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Insufficient Information | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Human-Device Interface Problem | 1 |
Incorrect Measurement | 1 |
High Readings | 1 |
| Total Device Problems | 45 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | International Rehabilitative Sciences, Inc. | II | Jun-26-2015 |
| 2 | Medtronic Navigation, Inc. | II | May-09-2014 |