The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Digital Transcutaneous Electrical Nerve Stimulator, Model Ev-803 Digital Tens.
| Device ID | K020749 |
| 510k Number | K020749 |
| Device Name: | DIGITAL TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR, MODEL EV-803 DIGITAL TENS |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-07 |
| Decision Date | 2002-10-31 |
| Summary: | summary |