Identity
- Trade Name
- Eccentron FDA UDI
- Generic Name
- Bicycle ergometer FDA UDI
- Device Name
- A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to lower extremity motion. It also measures strength and dynamic workload through its computer interface. FDA UDI
- Model / Reference
- LE1 FDA UDI
- Description
- A recumbent, closed-chain exercise device that provides eccentric (negative) resistance to lower extremity motion. It also measures strength and dynamic workload through its computer interface. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850390007816 FDA UDI
- FDA Product Code
- IKK FDA UDI
- GMDN Term
- Bicycle ergometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.1925 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bicycle ergometer
Eccentron by Bte Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Lode B.V. — Lode B.V. · Class II
- ERGOMETER EBIKE COMFORT US & BP — ergoline GmbH · Class II
- SYSTEM EBIKE EL EXT TRMNL 120V US — ergoline GmbH · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Bte Technologies
Sources (1)
- FDA UDI b5370b0d-e85b-46bd-a231-792c268ba352 35 fields · synced May 31, 2026