The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co.,ltd. with the FDA for Wireless Pain Relieve Device Model: Lt5018c.
Device ID | K173462 |
510k Number | K173462 |
Device Name: | Wireless Pain Relieve Device Model: LT5018C |
Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
Applicant | Shenzhen Dongdixin Technology Co.,Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate, Nansha Shenzhen, CN 51808 |
Contact | Siping Yuan |
Correspondent | Siping Yuan Shenzhen Dongdixin Technology Co.,Ltd. No. 3 Building Xilibaimang Xusheng Industrial Estate, Nansha Shenzhen, CN 51808 |
Product Code | NUH |
Subsequent Product Code | NGX |
Subsequent Product Code | NYN |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-08 |
Decision Date | 2017-12-08 |
Summary: | summary |