Clearance Summary
G-TRAINER MEDICAL received FDA 510(k) clearance under submission number K072887, sponsored by Alter-G, 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 2008-01-25.
- Submission: K072887
- Applicant / Sponsor: Alter-G, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5380
- Decision date: 2008-01-25
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.