510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
ISHClass I

Component, External, Limb, Ankle/Foot

21 CFR 890.3420 / Physical Medicine
FDA source (opens on fda.gov)

ISH is the FDA product code for Component, External, Limb, Ankle/Foot, a class I device type, regulated under 21 CFR 890.3420. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 13 recalls.

Classification record

Product code
ISH
Device name
Component, External, Limb, Ankle/Foot
Regulation
21 CFR 890.3420
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
4
Ingested recalls
13

Clearances, product code ISH

By decision year
4 clearances under product code ISH with a decision year between 1979 and 2005, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ISH by decision year
YearClearances
19791
19822
20051

Applicants with the most clearances

Product code ISH
Applicants holding the most 510(k) clearances under product code ISH
ApplicantClearances
Kiswood Manufacturing, Inc.1
Mauch Laboratories, Inc.1
Noble Fiber Technologies, Inc.1
Mizuho Orthopedic Systems Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 84 companies shown, in name order