FDA.reportPublic FDA data

"All Terrain Mountainner Knee Walker Single Folding 12"" / 12"""

Primary DI
00840117334427
Brand
"All Terrain Mountainner Knee Walker Single Folding 12"" / 12"""
Company
Dynarex Corporation
Model
10218
Published
2024-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00840117334427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117334427008401173344278401173344270840117334427

GMDN Terms#

Term, Definition table
TermDefinition
Knee walkerA non-powered mobility aid in the form of a framework with wheels, a padded knee rest, and a steering handle directly connected to the front wheels, intended to be operated by a person with a lower leg injury who propels the device by pushing on the ground with one foot while resting the knee of the injured leg on the knee rest. Also known as a knee scooter, it is intended as an alternative to crutches and walking frames for patients with non-weight-bearing lower leg injuries.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117320925Resp-O2 Incentive Spirometer. Tri-Flow Chamber361022021-04-22
00840117324510Dynarex Bari + Max Bariatric HD Composit Swing Down Rail129542022-11-01
00616784295015Metal Swing Rail129502022-05-09
00616784295114Composite Swing Rail129512022-05-09
00616784295213Q Assist Bar129522022-05-09
00616784295312Pivot Assist Bar129532022-05-09
00616784296012Universal Rotating Assist Bar129602022-05-09
00616784296111Universal Pivot Assist Bar129612022-05-09
00840117303478Expansion Kit for D300129142022-05-09
00840117348578Standard Sling Seat/Back Sling, Mesh10750MS2019-12-30
00840117348592Standard Sling Seat/Back Sling, Canvas10750CN2019-12-30
00840117348615Standard Sling Seat/Back Sling, Mesh With Commode Opening10751MS2019-12-30
00840117348639Standard Sling Seat/Back Sling, Canvas With Commode Opening10751CN2019-12-30
00840117348653Standard Seat/Back Sling - Canvas, Adult Large107522019-12-30
00616784075419Replacement Straps For Standard Slings107542021-04-19
00840117324527Bariatric HD Long-Term Care Bed, DB600, 5 Function Low Bed, Expands to 54"120142022-11-21
00840117302891Long-Term Care Bed, D100120012021-02-03
00840117302907Long Term Care Bed, D200120022021-02-03
00840117302914Long-Term Care Bed D300, 5 Function Low Bed120032021-02-03
00840117302945Bariatric HD Long-Term Care Bed, DB300, 5 Function Low Bed120132021-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876190253TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.ITJ2026-07-08
00194346283439EquateDrive Devilbiss HealthcareITJ2026-06-10
00199536930186BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930193BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930209BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930216BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00199536930223BluelineTransparent Supply Solutions Ltd.ITJ2026-05-15
00810178885022Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885039Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885046Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885053Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885060Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885077Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178885619Vive MobilityVIVE HEALTH LLCITJ2026-04-27
00810178887347Vive MobilityVIVE HEALTH LLCITJ2026-04-27
14895262504259SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504266SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504273SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504280SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504693HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504709HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504716HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
14895262504730HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
24895262504324SOUNDFUSEHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504226HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504233HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
54895262504240HOMLANDHongKong Pishon Medical Equipment Co., LimitedITJ2026-04-22
00815027011867DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28
00815027011881DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28
00815027012888DALTON ROLLATOR DALTON MEDICAL CORPORATIONITJ2025-10-28