FDA UDI
In Commercial Distribution
🇺🇸 United States
DST
DI: G535DST0
·
Model: DST8000
·
D.P.E MEDICAL LTD.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- DST
- Primary DI
- G535DST0
- Version / Model
- DST8000
- Catalog Number
- DST8000
- 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
- cbd51c5f-5f4e-4fda-bc78-2319f6b5078f
Device Description
The DST is designed for the gradual practice of stair-climbing skills for people undergoing physical rehabilitation. It features four steps with adjustable height from zero to 16.5 centimeters (0– 6.5 inches) between steps.
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 | G535DST1 | HIBCC | Crate | 1 | In Commercial Distribution | |
| Primary | G535DST0 | HIBCC |