AccessGUDID - DEVICE: LC570PW (00606509400541)

GUDID

Device Identifier (DI) Information

Brand Name: LC570PW
Version or Model: LC570PW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: Pride Mobility Products Corp

Primary DI Number: 00606509400541
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 041477449 *Terms of Use

Device Description: An electric positioning chair is a device with a motorized positioning control that is intended for medical purposes and that can be adjusted to various positions. The device is used to provide stability for patients with athetosis (involuntary spasms) and to alter postural positions.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
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?
10796	Stand-up chair, electric	An electrically-powered device designed to support a patient with a disability (e.g., geriatric, injured, disabled) in a sitting posture and helps the person via its self-raising mechanism to both to sit down from a standing position and stand up from a sitting position. The electrically-powered features may include a seat that can be elevated and tilted forward to help the person stand, and/or a seat composed of several articulated sections that tilt to facilitate the person's activities and comfort. It is neither a stander (which is intended to support a patient in a prolonged standing position) nor a wheelchair.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INO	Chair, Positioning, Electric

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: dc6dc426-17a8-4be8-a0c2-dcd98dc04726
Public Version Date: March 03, 2023
Public Version Number: 4
DI Record Publish Date: September 19, 2016