AccessGUDID - DEVICE: Strike Force Power Soccer Wheelchair (00860008065407)

GUDID

Device Identifier (DI) Information

Brand Name: Strike Force Power Soccer Wheelchair
Version or Model: 1633
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Northern Engineering and Manufacturing, Inc.

Primary DI Number: 00860008065407
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 943237370 *Terms of Use

Device Description: The Strike Force from Power Soccer Shop is the first wheelchair designed specifically for power soccer! Designed with a low center of gravity and wide wheelbase, the Strike Force is able to move with more agility and spin kick with more power than any other power wheelchair in the world! Equipped with top-notch components and built on a durable steel frame, this chair is ready for the rigors of elite competition.

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?
41877	Wheelchair, electric-motor-driven, occupant-controlled, powered-steering, non-collapsible	A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction are performed by the occupant of the device. The device cannot be folded or readily dismantled for transport.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ITI	Wheelchair, Powered

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: 4aa980dc-c941-4d70-a1df-1699ee28f4c3
Public Version Date: March 30, 2022
Public Version Number: 1
DI Record Publish Date: March 22, 2022