Kaye Products - Y3FS

GUDID 00810117141325

Medium Anterior Support Walker with Forearm Supports

Kaye Products, Inc.

Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable Handgrip disability-assistive walker, non-powered, foldable
Primary Device ID00810117141325
NIH Device Record Keyc2f698b6-f25b-4462-91d6-7031cebdd20c
Commercial Distribution StatusIn Commercial Distribution
Brand NameKaye Products - Y3FS
Version Model NumberY3FS
Company DUNS082364654
Company NameKaye Products, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810117141325 [Primary]

FDA Product Code

ITJWalker, Mechanical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-07-13
Device Publish Date2023-07-05

Devices Manufactured by Kaye Products, Inc.

00810117140007 - Kaye Products, W1/2B2023-07-13 Sm Child's Posture Control Walker/Gait Trainer, 2 wheels
00810117140014 - Kaye Products - W1/2BR2023-07-13 Small Child's Posture Control Walker/Gait Trainer. 4 Wheels
00810117140021 - Kaye Products - W1/2BS2023-07-13 Small Child's Posture Control Walker/Gait Trainer. 4 Wheels, Front Swivel
00810117140076 - Kaye Products - W1/2BRX2023-07-13 Small Child's Posture Control Walker /Gait Trainer /4 wheels/Rear Silent
00810117140083 - Kaye Products - W1/2BSX2023-07-13 Small Child's Posture Control Walker/Gait Trainer /Front Swivel/Rear Silent
00810117140090 - Kaye Products - W1B2023-07-13 Child's Posture Control Walker/Gait Trainer, 2 Wheels
00810117140106 - Kaye Products - W1BR2023-07-13 Child's Posture Control Walker/Gait Trainer, 4 Wheels
00810117140113 - Kaye Products - W1BS2023-07-13 Child's Posture Control Walker/Gait Trainer, 4 Wheels/Front Swivel

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