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

Assembly, Knee/Shank/Ankle/Foot, External

21 CFR 890.3500 / Physical Medicine
FDA source (opens on fda.gov)

ISW is the FDA product code for Assembly, Knee/Shank/Ankle/Foot, External, a class II device type, regulated under 21 CFR 890.3500. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 10 recalls.

Classification record

Product code
ISW
Device name
Assembly, Knee/Shank/Ankle/Foot, External
Regulation
21 CFR 890.3500
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
10

Clearances, product code ISW

By decision year
1 clearance under product code ISW with a decision year between 1999 and 1999, 1999 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ISW by decision year
YearClearances
19991

Applicants with the most clearances

Product code ISW
Applicants holding the most 510(k) clearances under product code ISW
ApplicantClearances
Otto Bock Orthopedic Industry, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code