The following data is part of a premarket notification filed by M.i.tech Co.,ltd with the FDA for Hanarocare Reju.
| Device ID | K160893 |
| 510k Number | K160893 |
| Device Name: | HANAROCare ReJu |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | M.I.TECH CO.,LTD 174, HABUK 2-GIL, JINWI-MYEON Pyeongtaek-si, KR 17706 |
| Contact | Hwang Mi-sung |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 800 ROOSEVELT STE 417 Irvine, CA 92620 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-31 |
| Decision Date | 2016-07-27 |
| Summary: | summary |