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 |