AccessGUDID - DEVICE: FDM-SX (B915012430050)

GUDID

Device Identifier (DI) Information

Brand Name: FDM-SX
Version or Model: 01243005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NA
Company Name: zebris MEDICAL GmbH

Primary DI Number: B915012430050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328971791 *Terms of Use

Device Description: Platform for pressure distribution measurement under the human feet, intended for the analysis of the static and dynamic loads, as well as the individual gait parameters.

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?
35757	Gait analysis system	An assembly of mains electricity (AC-powered) devices and instruments intended to be used to study walking or running patterns. The device uses a platform/mat that measures ground reaction forces or relative pressures (e.g., foot pressure mapping), and/or uses cameras to determine knee, ankle, and hip joint movements and to measure forces and torques. It can be used to diagnose problems related to walking or running and to help plan corrective actions.	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
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 36059b7d-c53e-4daf-bd12-12d2af1ba8c9
Public Version Date: August 21, 2023
Public Version Number: 1
DI Record Publish Date: August 11, 2023