The following data is part of a premarket notification filed by Remed Co., Ltd with the FDA for Talent-pro Electromagnetic Stimulator.
| Device ID | K202031 |
| 510k Number | K202031 |
| Device Name: | Talent-Pro Electromagnetic Stimulator |
| Classification | Stimulator, Muscle, Powered |
| Applicant | Remed Co., Ltd #301-#303 Migun Techno World II, 187, Techno 2-Ro Yuseong-gu Daejeon, KR 34025 |
| Contact | Yoonsoo Nam |
| Correspondent | Kyungyoon Kang K-Biotech 201 South 4th Street, Suite 727 San Jose, CA 95112 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-22 |
| Decision Date | 2021-05-06 |