Clearance Summary
MYO-TRODE SG DISPOSABLE ELECTRODE received FDA 510(k) clearance under submission number K040400, sponsored by Myotronics-Noromed, Inc.. 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 2004-07-20.
- Submission: K040400
- Applicant / Sponsor: Myotronics-Noromed, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class II
- Regulation citation: 21 CFR 890.5850
- Decision date: 2004-07-20
Classification & Regulation
This clearance is catalogued under FDA product code NUW and 21 CFR 890.5850, within the Physical Medicine review panel as a Class II device.