510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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KNPClass I

Orthosis, Corrective Shoe

21 CFR 890.3475 / Physical Medicine
FDA source (opens on fda.gov)

KNP is the FDA product code for Orthosis, Corrective Shoe, a class I device type, regulated under 21 CFR 890.3475. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KNP
Device name
Orthosis, Corrective Shoe
Regulation
21 CFR 890.3475
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
7
Ingested recalls
0

Clearances, product code KNP

By decision year
7 clearances under product code KNP with a decision year between 1979 and 1983, 1983 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KNP by decision year
YearClearances
19791
19801
19811
19821
19833

Applicants with the most clearances

Product code KNP
Applicants holding the most 510(k) clearances under product code KNP
ApplicantClearances
Fred Sammons, Inc.2
Alimed, LLC1
Hamilton Kent1
Ipos Luneburg1
J.E. Hanger & Co., Ltd.1
Warm & Form, Orthopedic Materials1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 200 companies shown, in name order