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

Orthosis, Thoracic

21 CFR 890.3490 / Physical Medicine
FDA source (opens on fda.gov)

IPT is the FDA product code for Orthosis, Thoracic, a class I device type, regulated under 21 CFR 890.3490. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IPT
Device name
Orthosis, Thoracic
Regulation
21 CFR 890.3490
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
5
Ingested recalls
0

Clearances, product code IPT

By decision year
5 clearances under product code IPT with a decision year between 1976 and 1997, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IPT by decision year
YearClearances
19761
19812
19821
19971

Applicants with the most clearances

Product code IPT
Applicants holding the most 510(k) clearances under product code IPT
ApplicantClearances
Fred Sammons, Inc.2
Hill-Rom Inc.1
Roger Cestac & Assoc.1
Surgical Appliance Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 129 companies shown, in name order