Lode B.V. 960901
by Lode B.V.
Lode B.V. 960901 is a Class II device made by Lode B.V., cleared under FDA 510(k) K851097 on 18 Jun 1985 and listed in FDA GUDID since 9 May 2017 (UDI-DI 08717524640033), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08717524640033 | Date9 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK851097 | Date18 Jun 1985 | StatusActive |
Official records
- AccessGUDID record 08717524640033
- FDA 510(k) database K851097
Across registries
- FDA 510(k) K851097 decided 18 Jun 1985 Active
- FDA GUDID UDI-DI 08717524640033 listed 9 May 2017 Listed
Timeline
- Cleared FDA 510(k) K851097
- Listed FDA GUDID 08717524640033
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Lode B.V.
- Generic name
- Bicycle ergometer
- Model / reference
- 960901
- Primary DI / UDI-DI
- 08717524640033
- 510(k) Number
- FDA product code
- ISD
- GMDN term
- Bicycle ergometer
- Device class
- Class II
- Regulation number
- 890.5360
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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