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 |