The following data is part of a premarket notification filed by Astek Technology Ltd. with the FDA for Tens And Ems Stimulator, Tens Stimulator.
| Device ID | K183074 |
| 510k Number | K183074 |
| Device Name: | TENS And EMS Stimulator, TENS Stimulator |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Astek Technology Ltd. No. 118 Taizih Rd., Rende Dist Tainan City, TW 71741 |
| Contact | You-jhe Lin |
| Correspondent | You-jhe Lin Astek Technology Ltd. No. 118 Taizih Rd., Rende Dist Tainan City, TW 71741 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-05 |
| Decision Date | 2020-01-11 |