The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Comfy Series: Ev-804, Ev-805 & Ev-806.
| Device ID | K071951 |
| 510k Number | K071951 |
| Device Name: | COMFY SERIES: EV-804, EV-805 & EV-806 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| 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 | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-16 |
| Decision Date | 2007-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B3671100300 | K071951 | 000 |
| B36711002L00 | K071951 | 000 |
| 10816924020300 | K071951 | 000 |
| 10816924020287 | K071951 | 000 |
| 10816924020263 | K071951 | 000 |
| 10816924020256 | K071951 | 000 |
| 10816924020249 | K071951 | 000 |
| 10850209007075 | K071951 | 000 |