AccessGUDID - DEVICE: AlterG Anti-Gravity Treadmill (00850022788017)

GUDID

Device Identifier (DI) Information

Brand Name: AlterG Anti-Gravity Treadmill
Version or Model: Fit X
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Lifeward CA, Inc.

Primary DI Number: 00850022788017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 614284649 *Terms of Use

Device Description: The Fit X Anti-Gravity Treadmill is intended to be an entry level product used in a clinical setting for standing, walking, or running in place for rehabilitation, or conditioning for individuals that may require or benefit from the use of body weight support

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?
61495	Pneumatic-support treadmill	A mains electricity (AC-powered) device intended to create an anti-gravity effect to facilitate standing and in-place walking or running of a patient with a lower extremity injury/disorder during rehabilitation; it may also be used for obesity weight reduction and to help improve cardiovascular fitness. It consists of a speed-regulated treadmill (an endless, shock-absorbing rubber belt rotating on rollers); an air-inflatable chamber intended to encircle the patient’s lower body to provide pressure for weight support; an operator control unit to regulate treadmill speed/elevation and air-pressure weight support level; and side-mounted rails for the patient to hold for stabilization.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXB	Exerciser, 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: 71723577-6647-4e7e-8cea-62da665f98f2
Public Version Date: April 03, 2024
Public Version Number: 2
DI Record Publish Date: October 06, 2020