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

Stroller, Adaptive

21 CFR 890.3850 / Physical Medicine
FDA source (opens on fda.gov)

LBE is the FDA product code for Stroller, Adaptive, a class I device type, regulated under 21 CFR 890.3850. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LBE
Device name
Stroller, Adaptive
Regulation
21 CFR 890.3850
Device class
Class I
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
8
Ingested recalls
0

Clearances, product code LBE

By decision year
8 clearances under product code LBE with a decision year between 1978 and 2023, 1986 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code LBE by decision year
YearClearances
19781
19811
19821
19841
19862
20131
20231

Applicants with the most clearances

Product code LBE
Applicants holding the most 510(k) clearances under product code LBE
ApplicantClearances
Convaid Products LLC3
Asc Corp.1
Columbia Medical Mfg, LLC1
Kaye Products, Inc.1
Ki Mobility1
Mednet, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code