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

Stimulator, Muscle, Diagnostic

21 CFR 890.1850 / Physical Medicine
FDA source (opens on fda.gov)

ISB is the FDA product code for Stimulator, Muscle, Diagnostic, a class II device type, regulated under 21 CFR 890.1850. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ISB
Device name
Stimulator, Muscle, Diagnostic
Regulation
21 CFR 890.1850
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
5
Ingested recalls
0

Clearances, product code ISB

By decision year
5 clearances under product code ISB with a decision year between 1978 and 1984, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ISB by decision year
YearClearances
19782
19791
19842

Applicants with the most clearances

Product code ISB
Applicants holding the most 510(k) clearances under product code ISB
ApplicantClearances
Jay-Mar INternational Enterprises, in1
Med General1
Pirdy, Inc.1
Rami International Corp.1
Robert Bosch Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code ISB.