Clearance Summary
BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1 received FDA 510(k) clearance under submission number K875103, sponsored by Shield Computers , 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 1988-01-20.
- Submission: K875103
- Applicant / Sponsor: Shield Computers , Ltd.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.1615
- Decision date: 1988-01-20
Classification & Regulation
This clearance is catalogued under FDA product code IKE and 21 CFR 890.1615, within the Physical Medicine review panel as a Class I device.