IPX — Orthosis, Rib Fracture, Soft Class I

FDA Device Classification

FDA product code IPX covers "Orthosis, Rib Fracture, Soft", a Class I medical device regulated under 21 CFR 890.3490. Submissions are reviewed by the Physical Medicine panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
IPX
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
K823662warm and form, orthopedic materialsRIB BELT (UNIVERSAL)December 30, 1982
K823158warm and form, orthopedic materialsRIB BELT (UNIVERSAL)November 10, 1982
K803239danek medicalSOFTGOOD PRODUCTS AND SPLINTSJanuary 9, 1981