The following data is part of a premarket notification filed by Fuji Dynamics Limited with the FDA for Fd Ems, Model # D-fj30e.
| Device ID | K063642 |
| 510k Number | K063642 |
| Device Name: | FD EMS, MODEL # D-FJ30E |
| Classification | Stimulator, Muscle, Powered |
| Applicant | FUJI DYNAMICS LIMITED 01-03, 23/F, LAWS COMMERCIAL PLAZA, CHEUNG SHAWAN RD. Kowleon, Hong Kong, CN |
| Contact | Irene Cheung |
| Correspondent | Irene Cheung FUJI DYNAMICS LIMITED 01-03, 23/F, LAWS COMMERCIAL PLAZA, CHEUNG SHAWAN RD. Kowleon, Hong Kong, CN |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-07 |
| Decision Date | 2007-12-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857771003187 | K063642 | 000 |