Definition: TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES
| Device Type ID | 3755 |
| Device Name | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Regulation Description | Transcutaneous Electrical Nerve Stimulator For Pain Relief. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurostimulation Devices Psychiatry Branch (NSDP) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5890 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NUH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3755 |
| Device | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Product Code | NUH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Transcutaneous Electrical Nerve Stimulator For Pain Relief. |
| CFR Regulation Number | 882.5890 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AEMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ANDON HEALTH CO.,LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AVAZZIA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAYER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BAYER HEALTHCARE, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BAYER PHARMA, AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO.,LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMEDICAL ENTERPRISES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMEDICAL LIFE SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CENTER FOR PAIN AND STRESS RESEARCH, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EASYMED INSTRUMENT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EASYMED INSTRUMENTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EASYWELL BIOMEDICALS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
FUJI DYNAMICS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GEMORE TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEALTHCARE INNOVATIONS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEAT IN A CLICK LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HIVOX BIOTEK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOLLYWOG LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IQ TECHNOLOGIES INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
JKH HEALTH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFECARE LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MARC PRO | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIANATECHNOLOGIES CORP | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
NEUROMETRIX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEWMARK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OMRON HEALTHCARE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
PFIZER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PFIZER INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHILIPS CONSUMER LIFESTYLE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PINOOK USA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRIZM MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN EAPPLY TECHNOLOGY CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN JINGKEHUI ELECTRONIC CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SHENZHEN KENTRO MEDICAL ELECTRONICS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN OSTO TECHNOLOGY COMPANY LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SMARTMEDICALDEVICE CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUNMAS (H.K.) TRADING LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
THIMBLE BIOELECTRONICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TRIOWAVE TECHNOLOGIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TYECE LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WELL-LIFE HEALTHCARE LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 18 |
Insufficient Information | 9 |
Output Problem | 3 |
Overheating Of Device | 2 |
Torn Material | 1 |
Thermal Decomposition Of Device | 1 |
Failure To Conduct | 1 |
Failure To Power Up | 1 |
Off-Label Use | 1 |
Unexpected Shutdown | 1 |
Output Above Specifications | 1 |
Use Of Device Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operates Differently Than Expected | 1 |
Unintended Electrical Shock | 1 |
| Total Device Problems | 43 |