Lode B.V.

FDA UDI

Class II (US FDA UDI)

by Lode B.V.

Identity

Trade Name: Lode B.V. FDA UDI
Generic Name: Bicycle ergometer FDA UDI
Device Name: 967922 Angio rehab static wall fixation FDA UDI
Model / Reference: 967922 FDA UDI
Description: 967922 Angio rehab static wall fixation FDA UDI

Identifiers

Primary DI / UDI-DI: 08717524640545 FDA UDI
510(k) Number: K851097 FDA UDI
FDA Product Code: ISD FDA UDI
GMDN Term: Bicycle ergometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5360 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Bicycle ergometer

Lode B.V. by Lode B.V. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bicycle ergometer.

ERGOMETER EBIKE EL 120V US — ergoline GmbH · Class II
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Blood Pressure Cuff, infant — ergoline GmbH · Class II
ERGOMETER EBIKE COMFORT US & BP — ergoline GmbH · Class II
SYSTEM EBIKE EL EXT TRMNL 120V US — ergoline GmbH · Class II
ERGOMETER ergoselect 5 M — ergoline GmbH · Class II
SYSTEM EBIKE EL & BP 120V US — ergoline GmbH · Class II
ERGOMETER EBIKE III COMFORT — ergoline GmbH · Class II

Cleared under the same submission

K851097 also covers:

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: Lode B.V.

Sources (1)

FDA UDI a41f899f-2b7e-4f77-929b-eb47dc7ddf54 34 fields · synced May 30, 2026