FDA.reportPublic FDA data

Savaria

Primary DI
10688503300000
Brand
Savaria
Company
Savaria Concord Lifts Inc
Model
K2
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PCDPowered Stairway Chair Lift

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCDPowered Stairway Chair LiftPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10688503300000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1068850330000010688503300000

GMDN Terms#

Term, Definition table
TermDefinition
Mobile patient lifting system, battery-poweredA battery-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability, of any size and weight, safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, a patient holding device (e.g., a sling, holder or a frame), and a rechargeable battery. It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
245449095
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
10688503001006M-SERIESM929001M9290012019-11-22
10688503011005M-SERIESM929011M9290112019-11-22
10688503341072MonarchM929341-072019-11-22
10688503000610M-SERIESM2F272-1203-06-NA2024-10-08
10688503000603M-SERIESM2F200-1102-02-NA2024-08-29
10688503000580M-SERIESM2F200-1300-00-NA2024-08-19
10688503000597M-SERIESMBA454-1113-00-NA2024-08-19
10688503000573M-SERIESM2F200-1202-02-NA2024-07-18
10688503000566M-SERIESM4F200-1102-02-NA2024-06-27
10688503000559M-SERIESM4F200-1102-00-NA2024-06-18
10688503000542M-SERIESM2F272-1200-07-NA2024-05-09
10688503000535M-SERIESM4F272-1206-02-NA2024-05-02
10688503000528M-SERIESM2F272-1202-06-NA2024-04-24
10688503000511M-SERIESM2F272-1202-02-NA2024-04-22
10688503000474M-SERIESM2F130-1200-02-NA2024-04-18
10688503000481M-SERIESM2F200-1200-02-NA2024-04-18
10688503000498M-SERIESM2F272-1200-02-NA2024-04-18
10688503000504M-SERIESM2F272-1202-00-NA2024-04-18
10688503231076MonarchM929231-072024-04-15
10688503000467M-SERIESM2F200-1102-08-NA2024-04-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720892159823UP StairliftDeVi-Stairlifts B.V.PCD2026-08-19
08720892159830UP StairliftDeVi-Stairlifts B.V.PCD2026-08-19
08720892846327UP StairliftDeVi-Stairlifts B.V.PCD2026-08-19
08720892846334UP StairliftDeVi-Stairlifts B.V.PCD2026-08-19
08720892974402UP StairliftDeVi-Stairlifts B.V.PCD2026-08-19
08720892974426UP StairliftDeVi-Stairlifts B.V.PCD2026-08-19
08720892764003Otolift Otolift Trapliften B.V.PCD2026-01-23
04714379298826MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2025-01-10
04714379298833MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2025-01-10
04714379298703MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2024-08-09
04714379298710MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2024-08-09
04714379297966MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2024-04-30
04714379297737MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2024-04-16
04714379297744MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2024-04-16
00817650026225PinnacleHarmar Summit, LLCPCD2023-08-28
00817650026232PinnacleHarmar Summit, LLCPCD2023-08-28
00817650026249PinnacleHarmar Summit, LLCPCD2023-08-28
00817650026263PinnacleHarmar Summit, LLCPCD2023-08-28
00817650026270PinnacleHarmar Summit, LLCPCD2023-08-28
00817650026188PinnacleHarmar Summit, LLCPCD2023-08-15
00817650026195PinnacleHarmar Summit, LLCPCD2023-08-15
00817650026201PinnacleHarmar Summit, LLCPCD2023-08-15
00817650026218PinnacleHarmar Summit, LLCPCD2023-08-15
B24010Scalara SL1/CL2Garaventa (Canada) Ltd.PCD2023-06-27
B24011StairfriendGaraventa (Canada) Ltd.PCD2023-06-27
B240010Scalara SL1/CL2Garaventa (Canada) LtdPCD2023-06-27
B240110StairfriendGaraventa (Canada) LtdPCD2023-06-27
04714379297447MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2022-10-10
04714379297454MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2022-10-10
04714379297423MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2022-09-15