The following data is part of a premarket notification filed by Fuji Dynamics Limited with the FDA for Fdtens 2010.
| Device ID | K994266 |
| 510k Number | K994266 |
| Device Name: | FDTENS 2010 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | FUJI DYNAMICS LIMITED UNIT 103, 23/F, LAWS PLAZA 788 CHEUNG SHA WAN RD. Kowloon, HK |
| Contact | Toru Horiuchi |
| Correspondent | Toru Horiuchi FUJI DYNAMICS LIMITED UNIT 103, 23/F, LAWS PLAZA 788 CHEUNG SHA WAN RD. Kowloon, HK |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-17 |
| Decision Date | 2000-07-06 |