The following data is part of a premarket notification filed by Everyway Medical Instruments Co., Ldt. with the FDA for Balego Tens Digital Edition With Accessories For Pain Relief (otc).
| Device ID | K181207 |
| 510k Number | K181207 |
| Device Name: | Balego TENS Digital Edition With Accessories For Pain Relief (OTC) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Everyway Medical Instruments CO., LDT. 3 Fl., No. 5, Lane 155, Sec.3 Beishen Rd. New Taipei City, TW 22203 |
| Contact | Paul Hung |
| Correspondent | Aaron Hage DuVal & Associates 825 Nicollet Mall, Suite 1820 Minneapolis, MN 55402 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-07 |
| Decision Date | 2018-06-06 |
| Summary: | summary |