FDA.report

PROBASICS

Primary DI
00815067071029
Brand
PROBASICS
Company
COMPASS HEALTH BRANDS CORP.
Model
WKAJN2B
Device description
ProBasics Two-Button Walker without Wheels, Junior
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ITJWalker, Mechanical

Product Code Classifications

CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30815006707102PackageGS14In Commercial Distribution
00815067071029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3081500670710230815006707102
00815067071029008150670710298150670710290815067071029

GMDN Terms

TermDefinition
Handgrip disability-assistive walker, non-powered, foldableA non-powered, all- or partially-wheeled mobility aid in the form of a waist-high, foldable framework with handgrips and three or four legs designed to provide a stable support for a patient with a walking disability, a geriatric, obese, or infirm patient 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 patient holds and pushes in front of them as they walk. It is foldable for storage and transportation and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.

Sterilization Methods

Method

Contacts

PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags

DUNS number
827221698
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
false
Sterilization required before use
false

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00810178885503Vive MobilityVIVE HEALTH LLCITJ2026-02-03
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00810178887064Vive MobilityVIVE HEALTH LLCITJ2026-02-03
00810178887071Vive MobilityVIVE HEALTH LLCITJ2026-02-03
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06975960550602noneZhejiang Mateside Medical Devices Technology Co., LtdITJ2026-01-15
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