Cleared Traditional

K091242 - BANTAM

K091242 is an FDA 510(k) clearance for BANTAM, manufactured by Altimate Medical, Inc.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K091242 · Altimate Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
69d
Days
Class 2
Risk

K091242 is an FDA 510(k) clearance for the BANTAM. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Altimate Medical, Inc. (Elyria, US). The FDA issued a Cleared decision on July 6, 2009 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Altimate Medical, Inc. devices

FDA 510(k) Submission Details - K091242

510(k) Number K091242 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2009
Decision Date July 06, 2009
Days to Decision 69 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INO Device Classification - Class 2, Special Controls

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INO Chair, Positioning, Electric

All 11
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K091242.
LIFT CHAIR, MODEL T3
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LIFT CHAIR, MODEL C5
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EASYSTAND EVOLV
K062402 · Invacare Corp. · Sep 2006
MERITS MODEL E SERIES LIFT CHAIRS
K060212 · Merits Health Products Co., Ltd. · Mar 2006
MEDLINE ELECTRONIC POSITIONING CHAIR
K001937 · Medline Industries, Inc. · Sep 2000
INVACARE LIFT CHAIR
K002171 · Invacare Corp. · Aug 2000