AccessGUDID - DEVICE: DST (G535DSTTX0)

GUDID

Device Identifier (DI) Information

Brand Name: DST
Version or Model: DST8000 Triple XL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DST8000 Triple XL
Company Name: D.P.E MEDICAL LTD.

Primary DI Number: G535DSTTX0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 532608650 *Terms of Use

Device Description: DST8000 Triple XL combines three devices in one, including an adjustable staircase for walking up and down steps, a walking surface inclined at different angles, and a full horizontal parallel bars.

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):	Yes
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?
35058	Stair-climbing exerciser, non-powered	An exercise apparatus designed to simulate the motion of climbing stairs primarily to increase cardiovascular endurance by keeping the heart and respiration rates elevated over a continuous period (aerobics); it also promotes lower-body muscle strength. It may consist of static staircases, or steppers (also known as climbers) consisting of foot pedals or platforms with a manual/hydraulic/air piston drive system, and with side handrails and/or front handlebars. It may include workout program modes to adjust the resistance level, a monitor to display the workout time, distance, speed, calories burned, and heart rate; and handlebars with grip pulse sensors or wireless heart rate tools.	Active	false
46339	Parallel bar exerciser, powered	A mains electricity (AC-powered) exercise apparatus designed to assist a user in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. It typically consists of two parallel wooden or steel handrails each one supported by two poles and base plates; the user holds the bars, which are electrically height and/or width-adjustable, thus relieving his/her weight when walking. The device is intended to improve the user?s balance as well as coordination and flexibility; additionally, it can improve the muscle strength in the lower limbs.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRR	Bars, Parallel, 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: ab46269d-3a37-46bf-a60f-f707eb4590dc
Public Version Date: January 28, 2026
Public Version Number: 1
DI Record Publish Date: January 20, 2026