Identity
- Trade Name
- Biodex FDA UDI
- Generic Name
- Body flywheel exerciser FDA UDI
- Device Name
- CYCLE, UPPER BODY - CLINICAL PRO FDA UDI
- Model / Reference
- 950-148 FDA UDI
- Description
- CYCLE, UPPER BODY - CLINICAL PRO FDA UDI
Identifiers
- Catalog Number
- 950-148 FDA UDI
- Primary DI / UDI-DI
- 00718175001486 FDA UDI
- FDA Product Code
- BXB FDA UDI
- GMDN Term
- Body flywheel exerciser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5380 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Body flywheel exerciser
Biodex by Biodex Medical Systems — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Body flywheel exerciser.
- Biodex — Biodex Medical Systems · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biodex Medical Systems
Sources (1)
- FDA UDI 029b02ca-81f0-4395-9921-e1ec01abeb0a 34 fields · synced May 30, 2026