IQE — Orthosis, Lumbar Class I

FDA Device Classification

FDA product code IQE covers "Orthosis, Lumbar", a Class I medical device regulated under 21 CFR 890.3490. Submissions are reviewed by the Physical Medicine panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
IQE
Device Class
Class I
Regulation Number
890.3490
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K821682surgical appliance industriesTRUNCAL ORTHOSISJune 24, 1982
K820051obus formeOBUS FORME ORTHOPEDIC BRACE, UPRIGHTJanuary 29, 1982
K812719bandwagonPROSANA BELTOctober 6, 1981
K810450fred sammonsTRUNCAL ORTHOSISMarch 4, 1981