Duns Number:115273859
Device Description: Foray Design's Spring is an all-wheeled mobility aid (rolling walker) in the form of a wai Foray Design's Spring is an all-wheeled mobility aid (rolling walker) in the form of a waist-high, foldable framework with a continuous handgrip and four 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 includes a seat on which the user can rest and it is constructed of lightweight material 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.
Catalog Number
-
Brand Name
Foray
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ITJ
Product Code Name
Walker, Mechanical
Public Device Record Key
03aee88f-29a8-4f92-8ec0-d3ca4cce0705
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
November 04, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |