AccessGUDID - DEVICE: MotionTrak (B435MT07)

GUDID

Device Identifier (DI) Information

Brand Name: MotionTrak
Version or Model: MT07
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WESTERN SYSTEMS RESEARCH INC.

Primary DI Number: B435MT07
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 608365466 *Terms of Use

Device Description: No description.

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?
17242	Posturography system	An assembly of devices designed to test a patient's sensory, voluntary, and/or reflexive motor control of balance and mobility providing biofeedback for rehabilitation of balance problems. The patient is placed on a dedicated platform equipped with built-in sensors, transducer and/or force plates that register movement when he/she adjusts his/her centre of gravity (COG) alignment according to the doctor's instructions, or, the platform provokes destabilizing perturbations and the output is recorded to a computer where they are graphically reproduced. This device is used, e.g., for motor control test (MCT), posture studies, balance, mobility training, and/or sense of equilibrium studies.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KHX	Platform, Force-Measuring

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: 6b901720-1efd-40ff-bd73-3f6573aabd12
Public Version Date: July 05, 2023
Public Version Number: 1
DI Record Publish Date: June 27, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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