AccessGUDID - DEVICE: Push-Button Style Pelvic Lap Belt (07540147002992)

GUDID

Device Identifier (DI) Information

Brand Name: Push-Button Style Pelvic Lap Belt
Version or Model: D-0178-BELT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BELT
Company Name: Motion Concepts Inc

Primary DI Number: 07540147002992
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259777209 *Terms of Use

Device Description: Push-button pelvic lap belt for use on Motion Concepts UL Maxx wheelchair seating systems equipped with Ultra-Rails. Lap belts are available in 4 sizes (lengths): 35", 48", 60" and 71". (Mounting hardware is included). IMPORTANT: Pelvic lap belts are provided for postural support only and are NOT suitable for use as vehicle safety belt during occupied transport in a wheelchair.

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?
13356	Wheelchair/chair/stander occupant restraint/support	A rigid or non-rigid device, typically a strap, belt, bar, harness or vest designed to be attached to a wheelchair/chair/stander and/or its occupant to stabilize the occupant’s position for prevention of slips and/or falls from the appliance and/or to provide postural support. Some types may also be used to secure a wheelchair occupant in a wheelchair while travelling in a motor vehicle. This device may also include the extensions needed to attach this device and may be available in various sizes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IQB	Belt, Wheelchair

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: 0890f424-c15d-4205-834a-6ef4debde0e4
Public Version Date: October 18, 2023
Public Version Number: 3
DI Record Publish Date: June 22, 2023