The following data is part of a premarket notification filed by Bewell Connect Corp. with the FDA for Mytens Model: Bw-tsx.
| Device ID | K171026 |
| 510k Number | K171026 |
| Device Name: | Mytens Model: BW-TSX |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Bewell Connect Corp. Suite 410, 185 Alewife Brook Parkway Cambridge, MA 02138 |
| Contact | Jacob Chen |
| Correspondent | Jacob Chen Bewell Connect Corp. Suite 410, 185 Alewife Brook Parkway Cambridge, MA 02138 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-05 |
| Decision Date | 2017-11-01 |