Clearance Summary
TAI SHENG VARIOUS NEOX POWERED MUSCLE STIMULATOR received FDA 510(k) clearance under submission number K031310, sponsored by Tai Sheng Electrical Machinery Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 2004-04-12.
- Submission: K031310
- Applicant / Sponsor: Tai Sheng Electrical Machinery Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2004-04-12
Classification & Regulation
This clearance is catalogued under FDA product code IPF and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.