FDA.reportPublic FDA data

HIGHLANDER

Primary DI
00817650020643
Brand
HIGHLANDER
Company
Harmar Summit, LLC
Model
CPL
Catalog number
CPL1000WACO
Device description
COMMERCIAL PLATFORM LIFT, 1000 HOISTWAY, AC, OUTSIDE
Published
2016-09-28
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
INGElevator, wheelchair, portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INGElevator, Wheelchair, PortablePhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091881000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091881000RPL/CPL VERTICAL PLATFORM LIFTSHarmar Summit, LLC2009-07-01ING

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817650020643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817650020643008176500206438176500206430817650020643

GMDN Terms#

Term, Definition table
TermDefinition
Assistive passenger liftAn elevator designed to be used and operated by a person with a disability and to accommodate their assistive devices (e.g., a wheelchair) which move in a vertically shaft (up and down) to provide a method of transport between two or more vertical levels (e.g., floors in a building and ship decks).

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
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
B24013Stair-Lifts: PegasusGaraventa (Canada) Ltd.ING2025-01-30
B24001Vertical LiftsGaraventa (Canada) Ltd.ING2024-04-11
B24012Vertical Lifts Garaventa (Canada) Ltd.ING2024-04-08
M368FR566DGH8516PA1LUMEXGF HEALTH PRODUCTS, INC.ING2023-12-05
10688503100006SavariaSavaria Concord Lifts IncING2018-09-04
10688503230000SavariaSavaria Concord Lifts IncING2018-06-25
10688503360004SavariaSavaria Concord Lifts IncING2017-11-28
09120047770221LIFTKAR®Sano Transportgeraete GmbHING2017-04-21
09120047770283LIFTKAR®Sano Transportgeraete GmbHING2017-04-21
B24002Vertical LiftsGaraventa (Canada) Ltd.ING2016-09-28
B24003Stair-LiftGaraventa (Canada) Ltd.ING2016-09-28
B24004Stair-LiftsGaraventa (Canada) Ltd.ING2016-09-28
B24009Super-TracGaraventa (Canada) Ltd.ING2016-09-28
00817650020124HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020179HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020186HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020216HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020223HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020230HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020247HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020254HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020261HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020285HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020292HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020322HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020353HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020360HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020438HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020537HIGHLANDERHarmar Summit, LLCING2016-09-28
00817650020544HIGHLANDERHarmar Summit, LLCING2016-09-28