AccessGUDID - DEVICE: DYNAMICO (08055715700877)

GUDID

Device Identifier (DI) Information

Brand Name: DYNAMICO
Version or Model: DYNAMICO-4 OUTDOOR USE
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMESA SRL

Primary DI Number: 08055715700877
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 432070019 *Terms of Use

Device Description: Walking frame intended to provide support and safety to those subjects with reduced functional capacity of maintaining the upright position and walking independently; subjects with disabilities and impaired functional residual capacity or even semi-self-sufficient elderly subjects who must be protected during walking.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31119	Handgrip disability-assistive walker, non-powered, non-foldable	A non-powered, all- or partially-wheeled mobility aid in the form of a waist- or trunk-high, non-foldable framework with handgrips or hand-held frame 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 might be used for rehabilitation. It is constructed of lightweight metal, plastic, and rubber materials in the shape of a mobile support structure which the patient holds and pushes in front of them as they walk. It is non-foldable and may include a braking mechanism; it may be width-adjustable and some types may include a seat on which the patient can rest.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITJ	Walker, Mechanical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b0cb13a-ec8f-4906-afa2-cbee4f4fc6ed
Public Version Date: February 10, 2025
Public Version Number: 1
DI Record Publish Date: January 31, 2025