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Device Explorer · FDA GUDID · GMDN 10383

Bicycle ergometer

A device intended to be used to provide a quantitative measurement of the rate at which work (energy) is performed by a muscle or group of muscles under controlled conditions. It is operated by a person using their legs, usually the patient, undergoing assessm

US‑registered devices76in commercial distribution
Companies5labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription50%Rx‑only share
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Share of device records

Ergoline Gmbh4964%
Lode B.V.2330%
Medical Positioning, Inc.23%
Sport Medical Technology Inc.11%
Bte Technologies, Inc.11%

Top labelers

CompanyDevicesShare
Ergoline Gmbh4964%
Lode B.V.2330%
Medical Positioning, Inc.23%
Sport Medical Technology Inc.11%
Bte Technologies, Inc.11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ergoselect 5ergoselect 4Seat Ergometer ergoselect 150 P childergoselect 10ergoselect 12optibike basicergoselect 1Recumbent Ergometer ergoselect 600 P BPRecumbent Ergometer ergoselect 600 PERGOMETER ergoselect 5 MERGOMETER ergoselect 4 MERGOMETER EBIKE III COMFORTERGOMETER EBIKE III BasicSPLY EBIKE CUFF ADULT LARGESPLY EBIKE CUFF ADULTCOM module for use with the MAC 5500 ST electroc

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
ISDExerciser, Measuring78
ISDExerciser, measuring25
IONExerciser, Non-Measuring2
BXBExerciser, Powered1
IKKSystem, Isokinetic Testing And Evaluation1

GMDN & GCC registration

  • GMDN code 10383 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 50% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Weight (Kilogram) · 42Height (Centimeter) · 41Width (Centimeter) · 41Length (Centimeter) · 41Height (Millimeter) · 1Length (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

No closely related category with 50+ devices.

How many bicycle ergometer products are registered in the US?

76 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bicycle ergometer", from 5 companies. The largest labeler is Ergoline Gmbh with 64% of records.

Which FDA product codes apply?

ISD (Exerciser, Measuring), ISD (Exerciser, measuring), ION (Exerciser, Non-Measuring), BXB (Exerciser, Powered)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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