FDA UDI
In Commercial Distribution
🇺🇸 United States
NxSTEP
DI: 00718175004845
·
Model: 950-484
·
SPORT MEDICAL TECHNOLOGY INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- NxSTEP
- Primary DI
- 00718175004845
- Version / Model
- 950-484
- Catalog Number
- 950-484
- Company Name
- SPORT MEDICAL TECHNOLOGY INC.
- Labeler DUNS
- 145217304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-05-15
- Public Version
- 2
- Public Version Date
- 2026-02-05
- Public Version Status
- Update
- Public Device Record Key
- 536e96b3-028e-41d5-b3f0-3e4fc6597a59
Device Description
NxSTEP Unweighing System, without Harness
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| ITJ | Walker, Mechanical | Physical Medicine | 890.3825 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61942 | Mobile gait rehabilitation system, harness-support | A mobile assembly of battery-powered devices designed to assist a patient with a walking/balance disability (neurological, muscular, cardiovascular, or orthopaedic in origin) to regain lost motor function, by enabling the patient to walk over ground (i.e., not on a treadmill) whilst supported from above. It consists of a mobile rigid framework on electronically-controlled wheels, a patient harness with suspension assembly, and motion sensors; the device senses patient movements and automatically follows the patient. The patient is supported overhead to assist rehabilitation and provide fall protection. It is intended to be used in a clinical setting under professional supervision. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00718175004845 | GS1 |