The following data is part of a premarket notification filed by Jkh Usa, Llc with the FDA for Medi-direct Tens Pen.
| Device ID | K182671 |
| 510k Number | K182671 |
| Device Name: | Medi-Direct TENS Pen |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | JKH USA, LLC 1142 S. Diamond Bar Blvd, #861 Diamond Bar, CA 91765 |
| Contact | Bill Quanqin Dai |
| Correspondent | Bill Quanqin Dai JKH USA, LLC 1142 S. Diamond Bar Blvd, #861 Diamond Bar, CA 91765 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-26 |
| Decision Date | 2019-09-21 |
| Summary: | summary |