AccessGUDID - DEVICE: SENCILLA 2 POWERED CHAIR (05050962359109)

GUDID

Device Identifier (DI) Information

Brand Name: SENCILLA 2 POWERED CHAIR
Version or Model: SENCILLA 2 POWERTED CHAIR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SKLA3110
Company Name: THE HELPING HAND COMPANY (LEDBURY) LIMITED

Primary DI Number: 05050962359109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 397307240 *Terms of Use

Device Description: SENCILLA 2 POWERED CHAIR

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):	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?
65508	Assistive ergonomic chair, electrically-adjusted	An electrically-powered device intended to support and position a patient (disabled and/or discomforted) in a sitting posture while performing activities of daily living, including work-related activities. It is designed with at least one electrically-operated ergonomic adjustment (e.g., height and position adjustments) to provide improved personal body posture and/or to help prevent/reduce physical problems associated with poor mobility or sedentary lifestyle. It is not a wheelchair.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INM	Chair, With Casters

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: ae41cc16-70ee-4488-bbcb-518d19c383bb
Public Version Date: February 12, 2024
Public Version Number: 1
DI Record Publish Date: February 02, 2024