FDA UDI
In Commercial Distribution
🇺🇸 United States
DST
DI: G535DSTTPX0
·
Model: DST8000 Triple Pro XL
·
D.P.E MEDICAL LTD.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DST
- Primary DI
- G535DSTTPX0
- Version / Model
- DST8000 Triple Pro XL
- Catalog Number
- DST8000 Triple Pro XL
- Company Name
- D.P.E MEDICAL LTD.
- Labeler DUNS
- 532608650
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-20
- Public Version
- 1
- Public Version Date
- 2026-01-28
- Public Version Status
- New
- Public Device Record Key
- c997cb2b-3aa0-4c43-a3d8-2d895cb73d52
Device Description
DST8000 Triple Pro XL combines all the benefits of the DST Triple with the Pro system which monitors, tracks, and displays the patient’s gait and performance while practicing stairs, a slope and parallel bars.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IRR | Bars, Parallel, Powered | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | G535DSTTPX1 | HIBCC | Crate | 1 | In Commercial Distribution | |
| Primary | G535DSTTPX0 | HIBCC |