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

Vibrator, Therapeutic

21 CFR 890.5975 / Physical Medicine
FDA source (opens on fda.gov)

IRO is the FDA product code for Vibrator, Therapeutic, a class I device type, regulated under 21 CFR 890.5975. As of , FDA records hold 65 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
IRO
Device name
Vibrator, Therapeutic
Regulation
21 CFR 890.5975
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
65
Ingested recalls
2

Clearances, product code IRO

By decision year
65 clearances under product code IRO with a decision year between 1976 and 1996, 1991 the highest year at 12.
Show the numbers
510(k) clearances under FDA product code IRO by decision year
YearClearances
19761
19771
19802
19813
19822
19832
19841
19862
19872
19881
19903
199112
19923
19937
199411
199510
19962

Applicants with the most clearances

Product code IRO
Applicants holding the most 510(k) clearances under product code IRO
ApplicantClearances
Conair LLC.12
Fairform Mfg., Co., Ltd11
Fred Sammons, Inc.5
Wahl Clipper Corp3
Windmere Corp.3
Mcshirley Products, Inc.2
Ako USA, Inc.1
Alimed, LLC1
Associated Mills, Inc.1
Carapace, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 65 companies shown, in name order