ISH — Component, External, Limb, Ankle/Foot Class I

FDA Device Classification

Classification Details

Product Code
ISH
Device Class
Class I
Regulation Number
890.3420
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K051256noble fiber technologiesSILVERSEAL ORTHOTIC COMPONENT WITH X-STATICJuly 21, 2005
K823396orthopedic systemsFREE FLEX HEEL HEIGHT ADJUSTORNovember 29, 1982
K820505mauch laboratoriesANKLE/FOOT EXTERNALMarch 8, 1982
K791331kiswood manufacturingTHE TUCKER-SACH FOOT AND TUCKER-SYME FTAugust 3, 1979