FDA.reportPublic FDA data

Tek RMD

Primary DI
00811478030044
Brand
Tek RMD
Company
Matia Robotics (us), Inc.
Model
05
Catalog number
TEKRMD05
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.
Published
2021-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IPLWheelchair, Standup

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPLWheelchair, StandupPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191334000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191334000Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08Matia Robotics (Us), Inc.2020-05-29IPL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811478030044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811478030044008114780300448114780300440811478030044

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsibleA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.801.997.1812info@matiarobotics.com

Regulatory Flags#

DUNS number
080949236
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811478030013Tek RMD02TEKRMD022021-06-07
00811478030020Tek RMD03TEKRMD032021-06-07
00811478030037Tek RMD04TEKRMD042021-06-07
00811478030051Tek RMD06TEKRMD062021-06-07
00811478030068Tek RMD07TEKRMD072021-06-07
00811478030075Tek RMD08TEKRMD082021-06-07
00811478030006Tek Robotic Mobilization Device01TEKRMD012018-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613045038841LEVOLEVO AG WohlenIPL2026-02-26
07613045036762LEVOLEVO AG WohlenIPL2025-09-09
07613045038940LEVOLEVO AG WohlenIPL2025-09-09
07613045071503LEVOLEVO AG WohlenIPL2025-09-09
09356399060974Magic XT2RED MILAWA PTY. LTD.IPL2024-11-18
17330818002003PermobilPERMOBIL, INC.IPL2023-08-15
17330818000993PermobilPERMOBIL, INC.IPL2023-07-07
07540147011444MODULAR POWER STANDING SYSTEMMotion Concepts IncIPL2021-08-12
07540147011451MODULAR POWER STANDING SYSTEMMotion Concepts IncIPL2021-08-12
00811478030013Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030020Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030037Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030051Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030068Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00811478030075Tek RMDMatia Robotics (us), Inc.IPL2021-06-07
00016958059793Quickie Q700-UP M / Q700MSUNRISE MEDICAL (US) LLCIPL2021-05-03
04064406193656Paragolfer Power WheelchairOtto Bock Mobility Solutions GmbHIPL2020-09-15
00810058400031Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00810058400048Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00810058400055Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00859706005976Karman HealthcareKARMAN HEALTHCARE INC.IPL2020-08-10
00811478030006Tek Robotic Mobilization DeviceMatia Robotics (us), Inc.IPL2018-03-21
B289SS1F0SuperStand Standing WheelchairSTANDING COMPANY, THEIPL2017-01-30
00863444000308Redman/Chief Power ChairCHIEF POWER CHAIR, LLCIPL2016-12-19
08680905006905TEK Robotic Mobilization DeviceMATIA ROBOTICS MEKATRONIK SISTEMLER AR-GE MUHENDISLIK YAZILIM SANAYI VE TICARET A SIPL2016-09-25
B289HPS2SuperStand Standing WheelchairSTANDING COMPANY, THEIPL2016-09-24
B289PS2SuperStand Standing WheelchairSTANDING COMPANY, THEIPL2016-09-24
B289SS1SuperStand STANDING COMPANY, THEIPL2016-09-24
04032767048397ParaGolfer Power WheelchairOtto Bock Mobility Solutions GmbHIPL2016-09-15
04032767402526ParaGolfer Power wheelchairOtto Bock Mobility Solutions GmbHIPL2016-09-15