FDA UDI
In Commercial Distribution
🇺🇸 United States
Biodex
DI: 00718175001486
·
Model: 950-148
·
SPORT MEDICAL TECHNOLOGY INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Biodex
- Primary DI
- 00718175001486
- Version / Model
- 950-148
- Catalog Number
- 950-148
- Company Name
- SPORT MEDICAL TECHNOLOGY INC.
- Labeler DUNS
- 145217304
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-02
- Public Version
- 3
- Public Version Date
- 2026-02-05
- Public Version Status
- Update
- Public Device Record Key
- 029b02ca-81f0-4395-9921-e1ec01abeb0a
Device Description
CYCLE, UPPER BODY - CLINICAL PRO
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
- No
- 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 |
|---|---|---|---|---|
| BXB | Exerciser, Powered | Physical Medicine | 890.5380 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58500 | Body flywheel exerciser | An exercise apparatus intended to strengthen several of the major muscle groups of the body (i.e., in the arms, legs, chest, back) through repetitive body motion against a flywheel. During the muscle contraction phase resistance is provided by the inertia of the flywheel, which is subsequently set spinning to provide resistance during the muscle lengthening phase. It typically consists of a floor-standing platform with a pulley, axle, and connection disc for the attachment of flywheel weights, with an assortment of harnesses, straps and grips. The device typically enables the performance of a wide variety of exercise motions including curls, presses, lunges and raises. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00718175001486 | GS1 |