Lode B.V. 967903
by Lode B.V.
Lode B.V. 967903 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 1 Feb 2018 (UDI-DI 08717524640507), 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 | Number08717524640507 | Date1 Feb 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK851097 | Date18 Jun 1985 | StatusActive |
Official records
- AccessGUDID record 08717524640507
- FDA 510(k) database K851097
Across registries
- FDA 510(k) K851097 decided 18 Jun 1985 Active
- FDA GUDID UDI-DI 08717524640507 listed 1 Feb 2018 Listed
Timeline
- Cleared FDA 510(k) K851097
- Listed FDA GUDID 08717524640507
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- Withdrawn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
- 967903
- Primary DI / UDI-DI
- 08717524640507
- 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
Similar devices
Other devices filed under FDA product code ISD (Exerciser, measuring).
- STANDARD HEALTH BIKE MODEL 019 by Battle Creek Equipment Co.
- MFE COUCH ERGOMETER by Ketronic, Inc.
- Remote Speed Control by Th Charters, Inc.
- Lordex Lumbar Extension Machine by Lordex, Inc.
- Collins Pedalmate 2 by Warren E. Collins, Inc.
- Upper Body Exerciser by Henley Intl.
- Total Work Integrator, Model #940-110 by Biodan Medical Systems, Ltd.
- Exercise Bicycle by Henley Intl.
- Universal-Ergotest by Erich Jaeger GmbH
- Flexercycle by Medmetric Corp.