The following data is part of a premarket notification filed by Self Doctor Care, Llc with the FDA for Msls6qf Tens/pms Device.
Device ID | K193655 |
510k Number | K193655 |
Device Name: | MSLS6QF TENS/PMS Device |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | Self Doctor Care, LLC 8811 Teel Pkwy Ste 100, Unit 6141 Frisco, TX 75036 |
Contact | Wei Wei |
Correspondent | Wei Wei Self Doctor Care, LLC 8811 Teel Pkwy Ste 100, Unit 6141 Frisco, TX 75036 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-30 |
Decision Date | 2020-09-04 |