IPG — Shoe, Cast Class I

FDA Device Classification

FDA product code IPG covers "Shoe, Cast", a Class I medical device regulated under 21 CFR 890.3025. Submissions are reviewed by the Physical Medicine panel. At least 6 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
IPG
Device Class
Class I
Regulation Number
890.3025
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K024279ness-neuromuscular electrical stimulation systemsNESS CHILDREN SYSTEMFebruary 5, 2003
K790652togardTOGUARDApril 4, 1979
K781363cutler biomedicalCAST SHOEAugust 14, 1978
K780617ballert orthopedicEQUALIZERApril 18, 1978
K760575richard medical equipROCKER-SOLE CAST SANDALOctober 6, 1976
K760578parke-davisBALANCED CAST SOLESeptember 27, 1976