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

Vehicle, Motorized 3-Wheeled

21 CFR 890.3800 / Physical Medicine
FDA source (opens on fda.gov)

INI is the FDA product code for Vehicle, Motorized 3-Wheeled, a class II device type, regulated under 21 CFR 890.3800. As of , FDA records hold 351 510(k) clearances under this code, the most recent dated , and 22 recalls.

Classification record

Product code
INI
Device name
Vehicle, Motorized 3-Wheeled
Regulation
21 CFR 890.3800
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
353
Ingested recalls
22

Clearances, product code INI

By decision year
353 clearances under product code INI with a decision year between 1982 and 2026, 2003 the highest year at 33.
Show the numbers
510(k) clearances under FDA product code INI by decision year
YearClearances
19821
19832
19844
19854
19862
19872
19884
19898
19908
19913
199213
199413
19951
19969
199711
19986
19996
20008
200117
200212
200333
200421
200515
200614
200718
20087
200912
20105
20115
20121
20132
20141
20159
20161
20175
20183
20194
20201
20215
20226
20239
20248
202515
202619

Applicants with the most clearances

Product code INI
Applicants holding the most 510(k) clearances under product code INI
ApplicantClearances
Wu's Tech Co., Ltd.18
Heartway Medical Products Co., Ltd.15
Pride Health Care, Inc.14
C.T.M. Homecare Product, Inc.11
Zhejiang Innuovo Rehabilitation Devices Co., Ltd.11
Pride Mobility Products Corp10
MEDLINE INDUSTRIES, LP - Northfield9
Fortress Scientific, Ltd.8
Merits Health Products, Inc.7
Amigo Mobility Intl., Inc.6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 69 companies shown, in name order