Clearance Summary
EX N' FLEX EF-200 received FDA 510(k) clearance under submission number K925270, sponsored by Tecogics Scientific , 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 1993-07-21.
- Submission: K925270
- Applicant / Sponsor: Tecogics Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 1993-07-21
Classification & Regulation
This clearance is catalogued under FDA product code BXB and 21 CFR 890.5380, within the Physical Medicine review panel as a Class I device.