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

Massager, Powered Inflatable Tube

21 CFR 890.5650 / Physical Medicine
FDA source (opens on fda.gov)

IRP is the FDA product code for Massager, Powered Inflatable Tube, a class II device type, regulated under 21 CFR 890.5650. As of , FDA records hold 156 510(k) clearances under this code, the most recent dated , and 5 recalls.

Classification record

Product code
IRP
Device name
Massager, Powered Inflatable Tube
Regulation
21 CFR 890.5650
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
156
Ingested recalls
5

Clearances, product code IRP

By decision year
156 clearances under product code IRP with a decision year between 1978 and 2026, 2021 the highest year at 19.
Show the numbers
510(k) clearances under FDA product code IRP by decision year
YearClearances
19782
19821
19831
19841
19851
19861
19881
19891
19901
19911
19925
19952
19961
19971
19981
19991
20001
20012
20021
20032
20051
20072
20081
20091
20102
20113
20125
20132
20144
20152
20161
20174
20183
201910
20209
202119
202214
202310
202412
202513
202610

Applicants with the most clearances

Product code IRP
Applicants holding the most 510(k) clearances under product code IRP
ApplicantClearances
Daesung Maref Co.,Ltd8
Normatec Industries, LP7
Xiamen Weiyou Intelligent Technology Co.,Ltd7
MEGO AFEK AC Ltd.6
Wonjin Mulsan Co., Ltd.5
Chengdu Cryo-Push Medical Technology Co.,Ltd4
Zenith Technical Innovations, LLC4
Bio Compression Systems, Inc.3
JKH Health Co., Ltd.3
Maxstar Industrial Co Ltd3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 98 companies shown, in name order