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Lode B.V. 929900

by Lode B.V.

Lode B.V. 929900 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 11 May 2017 (UDI-DI 08717524640187), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K851097

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08717524640187 UDI-DI Date11 May 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK851097 Date18 Jun 1985DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K851097 decided 18 Jun 1985 Active
  • FDA GUDID UDI-DI 08717524640187 listed 11 May 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K851097
  2. Listed FDA GUDID 08717524640187

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lode B.V.
Generic name
Bicycle ergometer
Model / reference
929900
Primary DI / UDI-DI
08717524640187
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).

Other devices from Lode B.V.

  • Lode B.V. 965911

    Class II
  • Lode B.V. 965921

    Class II
  • Lode B.V. 967904

    Class II
  • Lode B.V. 960900

    Class II

See all devices from Lode B.V. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)