The following data is part of a premarket notification filed by Smartmedicaldevice Co., Ltd. with the FDA for Dr.music 3s.
Device ID | K172451 |
510k Number | K172451 |
Device Name: | Dr.MUSIC 3s |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | SmartMedicalDevice Co., Ltd. 32-19, Gobong-ro, Ilsandong-gu Goyang-si, KR 10364 |
Contact | Dong-min Lee |
Correspondent | Carmelina G. Allis The Allis Law Firm, PLLC 2437 Bay Area Blvd., #30 Houston, TX 77058 |
Product Code | NUH |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-14 |
Decision Date | 2017-11-17 |
Summary: | summary |