Clearance Summary
SD-970EMS ELECTRICAL MUSCULAR STIMULATOR received FDA 510(k) clearance under submission number K964434, sponsored by Skylark Device 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 1997-10-09.
- Submission: K964434
- Applicant / Sponsor: Skylark Device Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 1997-10-09
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.