AccessGUDID - DEVICE: Tek RMD (00811478030013)

GUDID

Device Identifier (DI) Information

Brand Name: Tek RMD
Version or Model: 02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TEKRMD02
Company Name: Matia Robotics (us), Inc.

Primary DI Number: 00811478030013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080949236 *Terms of Use

Device Description: The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander. It brings person from seated position to a passive standing position and have mobility.

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):	Yes
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?
40840	Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, 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 may be performed by an attendant or the occupant. The device may be disassembled or folded for transport.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
IPL	Wheelchair, Standup

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191334	000

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: d5a2a538-7745-4f1f-9dc5-42393939c8e2
Public Version Date: June 15, 2021
Public Version Number: 1
DI Record Publish Date: June 07, 2021