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

Treadmill, Powered

21 CFR 890.5380 / Physical Medicine
FDA source (opens on fda.gov)

IOL is the FDA product code for Treadmill, Powered, a class I device type, regulated under 21 CFR 890.5380. As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and 19 recalls.

Classification record

Product code
IOL
Device name
Treadmill, Powered
Regulation
21 CFR 890.5380
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
43
Ingested recalls
19

Clearances, product code IOL

By decision year
43 clearances under product code IOL with a decision year between 1976 and 1995, 1985 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code IOL by decision year
YearClearances
19764
19772
19803
19825
19832
19843
19857
19864
19881
19893
19901
19914
19932
19952

Applicants with the most clearances

Product code IOL
Applicants holding the most 510(k) clearances under product code IOL
ApplicantClearances
Quinton, Inc.9
Battle Creek Equipment3
Burdick Corp.3
Eaton Medical Group3
Erich Jaeger, Inc.2
Parker Treadmill Co., Inc.2
Physio Control, Inc.2
Siemens Burdick, Inc.2
Structural Analysis Systems, Inc.2
Biodan Medical Systems, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 25 companies shown, in name order