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

Head Halter, Traction

21 CFR 890.5925 / Physical Medicine
FDA source (opens on fda.gov)

IRS is the FDA product code for Head Halter, Traction, a class I device type, regulated under 21 CFR 890.5925. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
IRS
Device name
Head Halter, Traction
Regulation
21 CFR 890.5925
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 IRS

By decision year
1 clearance under product code IRS with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IRS by decision year
YearClearances
19771

Applicants with the most clearances

Product code IRS
Applicants holding the most 510(k) clearances under product code IRS
ApplicantClearances
Chattanooga Pharmacal Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 21 companies shown, in name order