FDA.reportPublic FDA data

KLYO

Primary DI
B773KMHBD0
Brand
KLYO
Company
KLYO MEDICAL SYSTEMS INC.
Model
KMHBD
Device description
A mechanical bed designed to be used as a patient bed for rest/sleep in a hospital ward/room with manual mechanisms to adjust the height and surface contour of the bed. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and mechanical manually-operated controls to operate the bed.
Published
2024-02-23
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
FNJBed, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNJBed, ManualGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B773KMHBD0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual hospital bedA mechanical bed designed to be used as a patient bed for rest/sleep in a hospital ward/room with manual mechanisms to adjust the height and surface contour of the bed. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and mechanical manually-operated controls to operate the bed.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3053305025sales@klyomedical.com

Regulatory Flags#

DUNS number
058639417
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B773KEHBD0KLYOKEHBD2024-02-23
B773KHSTR0KLYOKHSTR2024-02-23
B773KLEDL0KLYOKLED-L2024-02-22
B773KLEDS0KLYOKLED-S2024-02-22
B773KMOPT0KLYOKMOPT2024-02-22
B773KEOPT0KLYOKEOPT2024-02-21
B773KLTEM77KLYOKL2023-05-24
B773KLEDM0KLYOKLED-M2019-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
34895262521519HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521471HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521488HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521495HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521501HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521518HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521525HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
04895262521532HOMLANDHongKong Pishon Medical Equipment Co., LimitedFNJ2026-04-22
06975575170189YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
06975575170196YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
06975575170202YongXinJiangsu Yongxin Medical Equipment Co., Ltd.FNJ2026-03-26
05060631840548SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-21
05060631840005SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840012VoyagerSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840029Voyager CompactSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840500SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840517SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840760Safespace Hi-Lo CompartmentSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840524SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631840531SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
05060631843006Safespace on platform 19cmSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-12
50606318404940SafespaceSAFESPACES (CORNHOLME) LIMITEDFNJ2025-11-10
00766923348109Stay Safe BedPEDICRAFT, INC.FNJ2025-07-21
00766923348123Stay SafePEDICRAFT, INC.FNJ2025-07-21
00845699005437SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005444SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005451SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005468SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005475SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30
00845699005482SizewiseSIZEWISE RENTALS, L.L.C.FNJ2024-08-30