510(k) K831690

IPOS ANTI-ADDUCTUS SHOE by Ipos Luneburg — Product Code KNP

K831690 is an FDA 510(k) premarket notification submitted by Ipos Luneburg for the device "IPOS ANTI-ADDUCTUS SHOE". The FDA issued a decision of Substantially Equivalent on June 24, 1983. The device falls under product code KNP (Orthosis, Corrective Shoe), a Class I device regulated under 21 CFR 890.3475. Ipos Luneburg has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1983
Date Received
May 24, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Corrective Shoe
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type