FDA.reportPublic FDA data

Guardsman

Primary DI
00817650020070
Brand
Guardsman
Company
HARMAR SUMMIT, LLC
Model
Helix 3 LH Indoor
Catalog number
CSL500
Device description
Helix 3 LH NKEY Indoor chassis
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
00817650020070PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817650020070008176500200708176500200700817650020070

GMDN Terms#

Term, Definition table
TermDefinition
Stairlift, chairA mains electricity (AC-powered) lifting device with an attached seating unit to accommodate a person with a disability, a geriatric or an infirm person to be transported up and down a staircase in a sitting position. 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 for home-use and in public venues and institutions.

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00817650024399RaveRave-IIRave-II-FR-LH2020-11-10
00817650024412RaveRave-IIRave-II-FR-RH2020-11-10
00817650024429RaveRave-IIRave-II-FR-RH-D2020-11-10
00817650024436RaveRave-IIRave-II-FRLH-KNT2020-11-10
00817650024443RaveRave-IIRave-II-FRRH-KNT2020-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00817650026133Pinn LiteHARMAR SUMMIT, LLCPCD2022-07-25
00817650026065PinnacleHARMAR SUMMIT, LLCPCD2022-03-29
00817650026096PinnacleHARMAR SUMMIT, LLCPCD2022-03-29
00817650026126PinnacleHARMAR SUMMIT, LLCPCD2022-03-29
04714379296952MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2022-03-15
04714379296969MERITSMERITS HEALTH PRODUCTS CO., LTD.PCD2022-03-15
00817650025525Pinn LiteHARMAR SUMMIT, LLCPCD2021-04-07