The following data is part of a premarket notification filed by Fuji Dynamics Ltd with the FDA for Fd Tens 2090, Fd Tens 2095.
| Device ID | K152676 |
| 510k Number | K152676 |
| Device Name: | FD TENS 2090, FD TENS 2095 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | FUJI DYNAMICS LTD 1-3, 23/F., LAWS COMMERICAL PLAZA ,788 CHEUNG SHA WAN RD Hong Kong, CN |
| Contact | Man Chung Man |
| Correspondent | Man Chung Man FUJI DYNAMICS LTD 1-3, 23/F., LAWS COMMERICAL PLAZA ,788 CHEUNG SHA WAN RD Hong Kong, CN |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-18 |
| Decision Date | 2016-01-22 |
| Summary: | summary |