AccessGUDID - DEVICE: Power Recline Module (Kit) (07540147001810)

GUDID

Device Identifier (DI) Information

Brand Name: Power Recline Module (Kit)
Version or Model: D-0103-REC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REC
Company Name: Motion Concepts Inc

Primary DI Number: 07540147001810
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 259777209 *Terms of Use

Device Description: Low Profile Power Recline Module for use on Motion Concepts Power Positioning Systems. (Recline Angle Ranges Available: Adult (168°), Mini (161°), Bariatric (150°)).

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?
30101	Assistive lifting/tilting positioning system	A set of devices/components that are combined together designed to be used by a person with a disability that allows lifting and tilting movements of objects that they choose to position to keep them accessible.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNN	Components, 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: 35705bc9-3eea-4540-94b7-2539c5929c62
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022