The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Electrical Muscle Stimulator, Models N605 And N607.
| Device ID | K033544 |
| 510k Number | K033544 |
| Device Name: | ELECTRICAL MUSCLE STIMULATOR, MODELS N605 AND N607 |
| Classification | Stimulator, Muscle, Powered |
| 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 | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-10 |
| Decision Date | 2003-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10816924020270 | K033544 | 000 |