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

Band Or Belt, Pelvic Support

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

ISR is the FDA product code for Band Or Belt, Pelvic Support, a class I device type, regulated under 21 CFR 890.3025. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
ISR
Device name
Band Or Belt, Pelvic Support
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
1
Ingested recalls
0

Clearances, product code ISR

By decision year
1 clearance under product code ISR with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ISR by decision year
YearClearances
19791

Applicants with the most clearances

Product code ISR
Applicants holding the most 510(k) clearances under product code ISR
ApplicantClearances
Fred Sammons, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 145 companies shown, in name order