Cleared Traditional

K905113 - ROTO REST

Also marketed or referenced as:
TRAUMA AND INTENSIVE CARE BED

K905113 is an FDA 510(k) clearance for ROTO REST, manufactured by Ethos Medical Products , Ltd.. The device is a Class 2 Physical Medicine device with product code IKZ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K905113 · Ethos Medical Products , Ltd. · Physical Medicine device
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Nov 1990
Decision
13d
Days
Class 2
Risk

K905113 is an FDA 510(k) clearance for the ROTO REST. Classified as Bed, Patient Rotation, Powered (product code IKZ), Class II - Special Controls.

Submitted by Ethos Medical Products , Ltd. (Athlone, IE). The FDA issued a Cleared decision on November 26, 1990 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5225 - 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 Ethos Medical Products , Ltd. devices

FDA 510(k) Submission Details - K905113

510(k) Number K905113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1990
Decision Date November 26, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 115d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IKZ Device Classification - Class 2, Special Controls

Product Code IKZ Bed, Patient Rotation, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5225
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 - IKZ Bed, Patient Rotation, Powered

All 11
Devices cleared under the same product code (IKZ) and FDA review panel - the closest regulatory comparables to K905113.
PULMONEX DYNAMIC AIR THERAPY UNIT
K950756 · Hill-Rom, Inc. · May 1995
MODEL TURN Q PLUS AUTOMATIC TURNING MATTRESS WITH LOW AIR LOSS THERAPY
K950681 · Invacare Corp. · May 1995
KUDO (POWERED ROTATION BED)
K905390 · Kinetic Concepts, Inc. · Jan 1991
EMERSON MOTION BED 6-MS & 6-ME
K842604 · J. H. Emerson Co. · Jul 1984
EGERTON TURNING & TILTING BED
K834563 · Kinetic Concepts, Inc. · Jan 1984
ROTO REST KINETIC TREATMENT TABLE PEDIA
K822402 · Kinetic Concepts, Inc. · Oct 1982