FDA.reportPublic FDA data

Sierra

Primary DI
00817650020094
Brand
Sierra
Company
Harmar Summit, LLC
Model
Sierra outdoor
Catalog number
IL500
Device description
Incline stairway lift outdoor
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PCEPermanently mounted wheelchair platform lift

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCEPermanently Mounted Wheelchair Platform LiftPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817650020094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817650020094008176500200948176500200940817650020094

GMDN Terms#

Term, Definition table
TermDefinition
Stairlift, platformA mains electricity (AC-powered) device designed with a platform typically used to accommodate a user sitting in their wheelchair to be transported up and down a staircase. This electromechanical device is typically attached to one or more rails which follow the shape and angle of the staircase, but may be affixed in another manner. It will typically be installed in public venues, institutions, and for home-use.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)833-0478quality_team@harmar.com

Regulatory Flags#

DUNS number
144008062
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
00817650022807HIGHLANDERRPLFLC0400SDCI2017-02-24
00817650022890FREEDOM EASY RIDERPLFLR0400SACI2017-07-07
00817650022906FREEDOM EASY RIDERPLFLR0400SDCI2017-07-07
00817650022913FREEDOM EASY RIDERPLFLR0400SDCO2017-07-07
00817650022845HERCULES IICPLAG 0400PDCI2017-05-06
00817650026287HighlanderVPLX0600SACOVPLX0600SRAAO2025-06-12
00817650026294HighlanderVPLX400SRADCIVPLX0400SRADCI2025-06-12
00817650026300HighlanderVPLX400SRADCOVPLX0400SRADCO2025-06-12
00817650026317HighlanderVPLX600SRADCIVPLX0600SRADCI2025-06-12
00817650026324HighlanderVPLX600SRADCOVPLX0600SRADCO2025-06-12
00817650026331HighlanderVPLX0600SACIVPLX0600SRAAI2025-06-12
00817650026225PinnaclePinnacle, Rave, LeafSSL13012023-08-28
00817650026232PinnaclePinnacle, Rave, LeafSSL13022023-08-28
00817650026249PinnaclePinnacle, Rave, LeafSSL13032023-08-28
00817650026263PinnaclePinnacle, Rave, LeafSSL13002023-08-28
00817650026270PinnaclePinnacle HDSSL14002023-08-28
00817650026188PinnaclePinnacle, Rave, LeafSSL11002023-08-15
00817650026195PinnaclePinnacle, Rave, LeafSSL12002023-08-15
00817650026201PinnaclePinnacle, Rave, LeafSSL12012023-08-15
00817650026218PinnaclePinnacle, Rave, LeafSSL12022023-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714420070332EasyLiftLiftup A/SPCE2026-05-05
05714420070462EasyLiftLiftup A/SPCE2026-05-05
05714420101562EasyLiftLiftup A/SPCE2026-05-05
05714420103030EasyLiftLiftup A/SPCE2026-05-05
05714420103047EasyLiftLiftup A/SPCE2026-05-05
05714420103962EasyLiftLiftup A/SPCE2026-05-05
05714420104051EasyLiftLiftup A/SPCE2026-05-05
05714420104068EasyLiftLiftup A/SPCE2026-05-05
00817650026287HighlanderHarmar Summit, LLCPCE2025-06-12
00817650026294HighlanderHarmar Summit, LLCPCE2025-06-12
00817650026300HighlanderHarmar Summit, LLCPCE2025-06-12
00817650026317HighlanderHarmar Summit, LLCPCE2025-06-12
00817650026324HighlanderHarmar Summit, LLCPCE2025-06-12
00817650026331HighlanderHarmar Summit, LLCPCE2025-06-12
00642561000008BRUNO Vertical Platform Lift (VPL)Bruno Independent Living Aids, Inc.PCE2024-06-29
00642561000015Bruno Vertical Platform Lift (VPL)Bruno Independent Living Aids, Inc.PCE2024-06-29
00642561000022Bruno Vertical Platform Lift (VPL)Bruno Independent Living Aids, Inc.PCE2024-06-29
00642561000039Bruno Vertical Platform Lift (VPL)Bruno Independent Living Aids, Inc.PCE2024-06-29
00817650026157HighlanderHarmar Summit, LLCPCE2023-03-06
00817650026171HighlanderHarmar Summit, LLCPCE2023-03-06
00810050862288Powered Loading System (PLS) (Wheelchair, PM)LIFEPORT, LLCPCE2023-01-05
00810050862172Powered Loading System (PLS) (Wheelchair, PM)LIFEPORT, LLCPCE2022-09-07
00810050862035Powered Loading System (PLS) (Wheelchair, PM)LIFEPORT, LLCPCE2022-06-23
05714420032231FlexStepLiftup A/SPCE2021-06-03
05714420032538FlexStepLiftup A/SPCE2021-06-03
05714420033740FlexStepLiftup A/SPCE2021-06-03
05714420034587FlexStepLiftup A/SPCE2021-06-03
05714420036956FlexStepLiftup A/SPCE2021-06-03
05714420039629FlexStepLiftup A/SPCE2021-06-03
05714420041608FlexStepLiftup A/SPCE2021-06-03