FDA.reportPublic FDA data

TOTO Platform - INTERNATIONAL

Primary DI
05056279300131
Brand
TOTO Platform - INTERNATIONAL
Company
Frontier Therapeutics Inc
Model
4100001
Device description
TOTO Platform - INTERNATIONAL
Published
2021-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IKZBed, Patient Rotation, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKZBed, Patient Rotation, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056279300131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056279300131050562793001315056279300131

GMDN Terms#

Term, Definition table
TermDefinition
Alternating-pressure bed mattress overlay, reusableA pad or thin mattress, usually full-body length, which is placed on top of a bed mattress and designed with parallel chambers that are alternately filled with forced-air to actively change an occupant's bed contact points, typically to relieve pressure points for comfort and to prevent pressure sores. It is commonly used for elderly immobilized (especially in cases of decubitus ulcers), patients with disabilities, or patients with low body fat. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800)303-9544contactus@frontier-therapeutics.com

Regulatory Flags#

DUNS number
111598708
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00505627930841Repose Flex Large x10 &Pump x167501142026-06-05
05056279308434Repose Flex Large x1 & Pump x167500042026-06-05
05056279308458Repose Flex Large x10 &Pump x1077500042026-06-05
05056279301428Repose Mattress and Pump (Bulk Pack 10)6111002021-03-31
05056279301602Repose Cushion (Bulk Pack 10)62001012021-03-31
05056279302029Repose Footprotector (Pair) (Bulk Pack 10)65002002021-03-31
05056279302036Repose Long Footprotectors (Pair) (Bulk Pack 10)65002012021-03-31
05056279302258Repose Footprotector PLUS (Pair) (Bulk Pack 10)65111102021-03-31
05056279302296Repose Small Footprotector (Bulk Pack 10) with Pump65201002021-03-31
05056279302340Repose Extra Small Footprotector (Bulk Pack 10) with Pump65301002021-03-31
05056279302395Repose Small Footprotector Plus (Bulk Pack 10) with Pump65401002021-03-31
05056279302425Repose Small Footprotectors Plus (Single) and Pump65411032021-03-31
05056279302432Repose Extra Small Footprotector Plus (Bulk Pack 10) with Pump65501002021-03-31
05056279303279Repose Sole Protector x 1 with Small Pump69300012021-03-31
05056279303521Repose Trolley Mattress and Pump (10 Singles)76011002021-03-31
05056279303613Repose Mattress Overlay and Pump (10 Singles)70111002021-03-31
05056279303620Repose 1 Long Footprotector and Pump (10 Singles)70210002021-03-31
05056279303637Repose Long Footprotectors (pair) and Pump - 10 Singles70211002021-03-31
05056279303682Repose Mattress Cushion and Pump (10 Singles)71211012021-03-31
05056279303743Repose Cushion and Pump (10 Singles)72011002021-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817012031867K-6oem AIRE-TURN ASSISTKAP MEDICALIKZ2026-05-29
00817012031850K-6 TURN-ZONEKAP MEDICALIKZ2026-01-16
00817012031829K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-10-10
00817012031843K-Zoem EZ-TURNKAP MEDICALIKZ2025-10-10
00817012031775K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031782K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031799K-6oem AIRE-TURN ASSIST KAP MEDICALIKZ2025-09-26
00817012031737K-6 TURN-ZONEKAP MEDICALIKZ2025-09-04
00817012022179K-Z ZM ZMattKAP MEDICALIKZ2025-06-27
00817012031676K-Zoem EZ-TURNKAP MEDICALIKZ2025-04-04
00817012031621K-6 AIRE-TURN ASSISTKAP MEDICALIKZ2024-11-22
00817012031638K-Z EZ-TURNKAP MEDICALIKZ2024-11-22
00817012031607K-Z Z-TURNKAP MEDICALIKZ2024-09-20
00817012031614K-Z Z-TURNKAP MEDICALIKZ2024-09-20
B414PAR3A3FXX0The Freedom BedProBed Medical Technologies IncIKZ2024-09-05
00817012031577K-Z ZM ZMattKAP MEDICALIKZ2024-08-23
00817012031584K-Zoem EZ-TURNKAP MEDICALIKZ2024-08-23
00817012031591K-Z ZM ZMattKAP MEDICALIKZ2024-08-23
00817012031492K-Z ZM ZMattKAP MEDICALIKZ2024-07-19
00817012031546K-Z Z-TURNKAP MEDICALIKZ2024-07-19
00860006962203Pronova-O2Turn Medical, LLCIKZ2024-06-03
00860011685609SideLyerTHE SIDE LYER COMPANY, LLCIKZ2024-04-29
00817012031355K-6 TURN-ZONEKAP MEDICALIKZ2024-01-19
00817012031362K-6 TURN-ZONEKAP MEDICALIKZ2024-01-19
00860004936817EasyShiftSeneca Devices, Inc.IKZ2024-01-12
00860004936848EasyShiftSeneca Devices, Inc.IKZ2024-01-12
00817012031386K-6 TURN-ZONEKAP MEDICALIKZ2023-11-30
00817012031379K-Z Z-TURNKAP MEDICALIKZ2023-08-11
00817012031348K-6 TURN-ZONEKAP MEDICALIKZ2023-07-14
00817012031164K-Z iTURNKAP MEDICALIKZ2023-06-02