FDA.reportPublic FDA data

PremierPro

Primary DI
10818566010800
Brand
PremierPro
Company
SVS LLC
Model
7802
Catalog number
7802
Device description
Walker, Dual-Release Folding, Adjustable Height 32" - 39"
Published
2020-08-26
Public version status
New
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
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818566010800PackageGS14In Commercial Distribution
00818566010803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081856601080010818566010800
00818566010803008185660108038185660108030818566010803

GMDN Terms#

Term, Definition table
TermDefinition
Basic walker, foldableAn all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and four or three legs designed to provide a stable support to a person with a disability, a geriatric or an infirm person when standing or ambulating; it may also be used during rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials and in the form of a mobile support structure which the user holds and pushes in front of them as they walk. It is foldable for storage and transportation, and includes a braking mechanism; it may be width-adjustable and some types may include a seat on which the user can rest.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-531-7699info@s2s-global.com

Regulatory Flags#

DUNS number
831375089
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811220035495PremierPro882088202024-10-28
00811220035518PremierPro882188212024-10-28
10811220035430PremierProD5061D50612024-03-08
10811220035447PremierProD5062D50622024-03-08
10811220035454PremierProD5063D50632024-03-08
10811220035461PremierProD5064D50642024-03-08
10811220035478PremierProD5065D50652024-03-08
00811220035143PremierProFL1003DFL1003D2024-02-14
00811220035174PremierProFL1005DFL1005D2024-02-14
00811220035099PremierProFL1010DFL1010D2024-02-14
00811220035112PremierProFL1010SFFL1010SF2024-02-14
00811220034412PremierPro™31T1417531T141752022-12-19
00811220034443PremierPro™31T1617731T161772022-12-19
00811220034474PremierPro™31T1811631T181162022-12-19
00811220034504PremierPro™31T1818831T181882022-12-19
00811220034535PremierPro™31T2011631T201162022-12-19
00811220034566PremierPro™31T2010031T201002022-12-19
00811220034597PremierPro™31T2018831T201882022-12-19
00811220034627PremierPro™31T2210031T221002022-12-19
00811220034658PremierPro™31T2407531T240752022-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975960550749noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-05-25
06975960550701noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-03-24
00810178887392Vive MobilityVIVE HEALTH LLCITJ2026-02-18
00860014768644RideNwalkINNOMOTIVE L.L.CITJ2026-02-04
00860014768651RideNwalkINNOMOTIVE L.L.CITJ2026-02-04
00810178883882Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178883899Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885206Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885497Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885503Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178885510Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178887064Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178887071Vive MobilityVIVE HEALTH LLCITJ2026-02-03
04895262504016HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-01-26
00057475820213BIOS LivingThermor LtdITJ2026-01-19
06975960550602noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-15
06975185620166BaichenNINGBO BAICHEN MEDICAL DEVICES CO., LTDITJ2026-01-07
06975960551470VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-04
06975960551487VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-04
06979196001167RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001174RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001181RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001198RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001204RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001211RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001228RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001235RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001242RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06979196001259RollatorZhongshan Yungu daily products Co., LTD.ITJ2025-12-18
06975960551463VOCICZhejiang Mateside Medical Devices Technology Co., LtdITJ2025-12-03