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

Cover, Limb

21 CFR 890.3025 / Physical Medicine
FDA source (opens on fda.gov)

IPM is the FDA product code for Cover, Limb, a class I device type, regulated under 21 CFR 890.3025. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
IPM
Device name
Cover, Limb
Regulation
21 CFR 890.3025
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
6
Ingested recalls
1

Clearances, product code IPM

By decision year
6 clearances under product code IPM with a decision year between 1976 and 1987, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IPM by decision year
YearClearances
19761
19771
19781
19801
19821
19871

Applicants with the most clearances

Product code IPM
Applicants holding the most 510(k) clearances under product code IPM
ApplicantClearances
Fred Sammons, Inc.1
Hydro-Med Products, Inc.1
Mizuho Orthopedic Systems Inc1
Robert R. Moore1
Southwest Technologies Inc1
The Owenby Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 140 companies shown, in name order