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

Bed, Therapeutic, Ac-Powered, Adjustable Home-Use

21 CFR 880.5100 / General Hospital
FDA source (opens on fda.gov)

LLI is the FDA product code for Bed, Therapeutic, Ac-Powered, Adjustable Home-Use, a class II device type, regulated under 21 CFR 880.5100. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and 19 recalls.

Classification record

Product code
LLI
Device name
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Regulation
21 CFR 880.5100
Device class
Class II
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
19

Clearances, product code LLI

By decision year
2 clearances under product code LLI with a decision year between 1984 and 2002, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LLI by decision year
YearClearances
19841
20021

Applicants with the most clearances

Product code LLI
Applicants holding the most 510(k) clearances under product code LLI
ApplicantClearances
Contour, Inc.1
Craftmatic Organization, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 43 companies shown, in name order