The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Everyway Interferntial Stimulator, Model If-908.
Device ID | K110509 |
510k Number | K110509 |
Device Name: | EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908 |
Classification | Interferential Current Therapy |
Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 845 ARONSON LAKE COURT Roswell, GA 30075 |
Contact | Jay Mansour |
Correspondent | Jay Mansour EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 845 ARONSON LAKE COURT Roswell, GA 30075 |
Product Code | LIH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-02-22 |
Decision Date | 2011-06-20 |
Summary: | summary |