Clearance Summary
DX6605E-TENS, DX6605E-G, DX6609-G received FDA 510(k) clearance under submission number K082057, sponsored by Shenzhen Dongdixin Technology Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2009-02-26.
- Submission: K082057
- Applicant / Sponsor: Shenzhen Dongdixin Technology Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5890
- Decision date: 2009-02-26
Classification & Regulation
This clearance is catalogued under FDA product code GZJ and 21 CFR 882.5890, within the Neurology review panel as a Class II device.