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

Exerciser, Non-Measuring

21 CFR 890.5370 / Physical Medicine
FDA source (opens on fda.gov)

ION is the FDA product code for Exerciser, Non-Measuring, a class I device type, regulated under 21 CFR 890.5370. As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
ION
Device name
Exerciser, Non-Measuring
Regulation
21 CFR 890.5370
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
43
Ingested recalls
2

Clearances, product code ION

By decision year
43 clearances under product code ION with a decision year between 1976 and 2012, 1983 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code ION by decision year
YearClearances
19764
19775
19782
19793
19804
19814
19828
19839
19841
19851
19891
20121

Applicants with the most clearances

Product code ION
Applicants holding the most 510(k) clearances under product code ION
ApplicantClearances
Fred Sammons, Inc.18
Maddak, Inc.7
Hosmer Dorrance Corp.2
Lossing Orthopedic, Inc.2
Alt, Inc.1
Back Rite1
Fitness Equipment Co., Inc.1
I-Rep, Inc.1
Im-Able, Ltd.1
Innovative Products, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 248 companies shown, in name order