Clearance Summary
DEMI-WALKER (REGULAR) received FDA 510(k) clearance under submission number K772268, sponsored by Med Fusion Systems, 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 1977-12-20.
- Submission: K772268
- Applicant / Sponsor: Med Fusion Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3475
- Decision date: 1977-12-20
Classification & Regulation
This clearance is catalogued under FDA product code ITQ and 21 CFR 890.3475, within the Physical Medicine review panel as a Class I device.