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

Twister, Brace Setting

21 CFR 890.3410 / Physical Medicine
FDA source (opens on fda.gov)

ITO is the FDA product code for Twister, Brace Setting, a class I device type, regulated under 21 CFR 890.3410. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
ITO
Device name
Twister, Brace Setting
Regulation
21 CFR 890.3410
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 ITO

By decision year
1 clearance under product code ITO with a decision year between 1980 and 1980, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code ITO by decision year
YearClearances
19801

Applicants with the most clearances

Product code ITO
Applicants holding the most 510(k) clearances under product code ITO
ApplicantClearances
Ipos Luneburg1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order