FDA UDI
In Commercial Distribution
🇺🇸 United States
Biostep 2, 100-240 VAC
DI: 00718175002407
·
Model: 950-240
·
SPORT MEDICAL TECHNOLOGY INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Biostep 2, 100-240 VAC
- Primary DI
- 00718175002407
- Version / Model
- 950-240
- Company Name
- SPORT MEDICAL TECHNOLOGY INC.
- Labeler DUNS
- 145217304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-06
- Public Version
- 2
- Public Version Date
- 2026-02-05
- Public Version Status
- Update
- Public Device Record Key
- a4ab848d-7d52-4747-aeec-bd0313e9f570
Device Description
950-240 Biostep 2, 100-240 VAC
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 |
|---|---|---|---|---|
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10383 | Bicycle ergometer | A device intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions. It is operated by a person using their legs, usually the patient, undergoing assessment, treatment, training, or rehabiltation and measures this related muscle activity at defined workloads. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00718175002407 | GS1 |