The following data is part of a premarket notification filed by Shenzhen Siken 3d Technology Development Co., Ltd. with the FDA for Galvanic Spa, Model: Skb-1405.
| Device ID | K163470 |
| 510k Number | K163470 |
| Device Name: | Galvanic Spa, Model: SKB-1405 |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | ShenZhen Siken 3D Technology Development Co., Ltd. Siken Industrial Park, East Avenue No., 33 Songgang Street, Baoan District Shenzhen, CN |
| Contact | Kimi Xue |
| Correspondent | Jet Li Guangzhou LETA Testing Technology Co., Ltd 6F, No.1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-12 |
| Decision Date | 2017-06-02 |
| Summary: | summary |