The following data is part of a premarket notification filed by Fuji Dynamics Ltd with the FDA for Fd Tens 2050 Or Slide Tens Model Fd2050.
| Device ID | K111645 |
| 510k Number | K111645 |
| Device Name: | FD TENS 2050 OR SLIDE TENS MODEL FD2050 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | FUJI DYNAMICS LTD UNIT 1-3, 23/F LAWS COMMERICAL PLAZA 788 CHEUNG SHA WAN RD Hong Kong, CN Ch |
| Contact | Ching Kong (felix) Lee |
| Correspondent | Ching Kong (felix) Lee FUJI DYNAMICS LTD UNIT 1-3, 23/F LAWS COMMERICAL PLAZA 788 CHEUNG SHA WAN RD Hong Kong, CN Ch |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-13 |
| Decision Date | 2011-11-09 |
| Summary: | summary |