FDA.reportPublic FDA data

KLYO

Primary DI
B773KHSTR0
Brand
KLYO
Company
KLYO MEDICAL SYSTEMS INC.
Model
KHSTR
Device description
A battery-powered mobile platform designed to transport a recumbent patient within a healthcare facility (e.g., to and from beds, chairs, treatment facilities, wheelchairs, and transportation vehicles). It typically includes a fixed, wheeled undercarriage, batteries, electric motor(s), and steering/operative controls. Some types, when fitted with a radiolucent surface, may be used for the acquisition of radiographic images.
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
FPOStretcher, Wheeled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPOStretcher, WheeledGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B773KHSTR0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hospital stretcher, poweredA battery-powered mobile platform designed to transport a recumbent patient within a healthcare facility (e.g., to and from beds, chairs, treatment facilities, wheelchairs, and transportation vehicles). It typically includes a fixed, wheeled undercarriage, batteries, electric motor(s), and steering/operative controls. Some types, when fitted with a radiolucent surface, may be used for the acquisition of radiographic images.

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
B773KMHBD0KLYOKMHBD2024-02-23
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
0019079000638935X PROFLEXXFERNO-WASHINGTON, INC.FPO2026-03-24
00190790006570POWER F2FERNO-WASHINGTON, INC.FPO2026-03-24
00190790006600POWER X2FERNO-WASHINGTON, INC.FPO2026-03-24
G782MPC1000Prone CartElectro-Connect, Inc.FPO2026-03-19
00887761005419Dynamo Series StretcherHILL-ROM, INC.FPO2026-02-19
00887761005457Side rail PadHILL-ROM, INC.FPO2026-02-19
00850073470091Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2026-01-27
08592654554524Sprint 100L I N E T spol. s r.o.FPO2026-01-07
00841027102755Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FPO2025-11-26
00841027102762Pedigo Products, Inc. PEDIGO PRODUCTS, INC.FPO2025-11-26
00850073470084Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-10-02
00190790003210POWER X2FERNO-WASHINGTON, INC.FPO2025-09-10
00817492013223NOA Medical IndustriesHoffmann NOA Medical Industries, LLCFPO2025-06-19
M3685B800STPD1HaustedGF HEALTH PRODUCTS, INC.FPO2025-06-11
M3685B800ST1HaustedGF HEALTH PRODUCTS, INC.FPO2025-06-11
00850073470015Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23
00850073470022Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23
00850073470039Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23
00850073470046Sechrist Industries, Inc.SECHRIST INDUSTRIES, INC.FPO2025-04-23
B237ZTGACA020Zephyr Patient StretcherDiacor, Inc.FPO2025-03-27
06974583360056HeruiZhangJiaGang Herui Medical Equipment Co.,LtdFPO2024-10-14
00850010988764Mor-Medical New EraMoroles Investments, LLCFPO2024-07-17
07613327613643Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
07613327622690Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
07613327623444Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
07613327623451Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
07613327623475Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
07613327623482Prime SeriesSTRYKER CORPORATIONFPO2024-05-06
07350016061797TR Stretcher without side rails Tr Equipment ABFPO2023-12-12
07350016061803TR Stretcher incl. side rails R & LTr Equipment ABFPO2023-12-12