The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ltd. with the FDA for Neuromuscular Electrical Stimulator, Model Ev-807p.
| Device ID | K033140 |
| 510k Number | K033140 |
| Device Name: | NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P |
| Classification | Stimulator, Muscle, Powered |
| Applicant | EVERYWAY MEDICAL INSTRUMENTS CO., LTD. 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Contact | Jay Mansor |
| Correspondent | Jay Mansor 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 | 2003-09-30 |
| Decision Date | 2003-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719871184363 | K033140 | 000 |