BANTAM— 510(k) K091242

Name: FDA 510(k) clearance K091242
Creator: U.S. Food and Drug Administration
Published: 2009-07-06

Substantially Equivalent

Altimate Medical, Inc.

FDA 510(k) clearance K091242 for BANTAM, Substantially Equivalent on 2009-07-06. Applicant: Altimate Medical, Inc.. Device class: 2.

Clearance details

Applicant: Altimate Medical, Inc.
Product code: Code INO
Device class: Class 2
Regulation: 21 CFR 890.3110
Advisory panel: Physical Medicine
Date received: 2009-04-28
Decision date: 2009-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code INO

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K131909 — DALTON LIFT CHAIR2014-02-24
K123834 — EASYSTAND BANTAM MEDIUM2013-08-13
K112944 — FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIES2011-12-30
K101723 — COMPACT WHEELCHAIR PLATFORM2010-12-23
K091578 — LIFT CHAIR, MODEL T32009-12-02

Adverse events under product code INO

product code INO

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K091242

K-number listed on FDA's recall record

Z-0243-2023 — EasyStand Bantam, with the following sizes. a. Small; b. Extra Small. Used for assisting individual in standing.Class II·Terminated·Altimate Medical, Inc.·20221004

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091242.

Data sourced from openFDA. This site is unofficial and independent of the FDA.