Clearance Summary
NESS CHILDREN SYSTEM received FDA 510(k) clearance under submission number K024279, sponsored by Ness-Neuromuscular Electrical Stimulation Systems. 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 2003-02-05.
- Submission: K024279
- Applicant / Sponsor: Ness-Neuromuscular Electrical Stimulation Systems
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3025
- Decision date: 2003-02-05
Classification & Regulation
This clearance is catalogued under FDA product code IPG and 21 CFR 890.3025, within the Physical Medicine review panel as a Class I device.