AccessGUDID - DEVICE: ActiveStep (00860003532010)

GUDID

Device Identifier (DI) Information

Brand Name: ActiveStep
Version or Model: 008-A ActiveStep
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SIMBEX LLC

Primary DI Number: 00860003532010
Issuing Agency: GS1
Commercial Distribution End Date: August 22, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 015704559 *Terms of Use

Device Description: The ActiveStep is an instrumented treadmill for pre-emptive rehabilitation, gait analysis and research. The ActiveStep system consists of a powered treadmill; harness and support structure; Intertial Measurement Unit (IMU) and computer for control and data acquisition.

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?
33015	Standard treadmill, powered	A mains electricity (AC-powered) device designed to facilitate in-place walking, jogging, or running to promote muscle redevelopment, to restore motion to joints, and to promote weight loss and cardiovascular fitness. It consists of an endless, continuous track (e.g., a shock-absorbing rubber belt rotating on rollers) on which the patient exercises that can be set to rotate at varying speeds, electric motors, and a control unit (to regulate belt speed/elevation, display related data, and activate an emergency stop). It will typically incorporate front and side-mounted rails to allow patients to steady themselves while in motion.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IOL	Treadmill, Powered

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: 6c4bab25-7047-42c1-a4bf-bb423846c37b
Public Version Date: August 23, 2023
Public Version Number: 2
DI Record Publish Date: May 01, 2020