The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Everyway Traction Unit, Model Ever-trac Et-800.
| Device ID | K112074 |
| 510k Number | K112074 |
| Device Name: | EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 |
| Classification | Equipment, Traction, Powered |
| 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 | ITH |
| CFR Regulation Number | 890.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-20 |
| Decision Date | 2012-02-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871180297 | K112074 | 000 |