# Aerobika

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/aerobika-110501>
- Manufacturer: [Trudell Medical International](https://devicerts.com/manufacturers/fda-fei-3001610754) (Canada)
- Device class: Class I (EU MDR); Class II (US FDA)
- FDA product code: BWF
- EMDN: R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 762860OPEP1G4 · UDI-DI 00762860100022 · registered 2022-03-30 · status: Active
- **510(k)** · FDA 510(k) · United States · K150173 · decision 2015-10-15 · decision SESE · status: Active

## Recalls

No recall on record.

## Identity

- Device name: Aerobika\* Oscillating Positive Expiratory Pressure Device [EUDAMED]
- Model / reference: 110501 [EUDAMED]

## Identifiers

- Primary DI / UDI-DI: 00762860100022 [EUDAMED]
- Basic UDI-DI: 762860OPEP1G4 [EUDAMED]
- 510(k) Number: K150173 [FDA 510(k)]
- FDA product code: BWF [FDA 510(k)]
- EMDN code: R9099 [EUDAMED]

## Classification

- Device class: Class I [EUDAMED]; Class II [FDA 510(k)]
- Regulation: 21 CFR Part 868.5690 [FDA 510(k)]
- EU registration type: Standard device [EUDAMED]
- EU market of registration: Türkiye [EUDAMED]
- Advisory committee: Anesthesiology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Properties

- Supplied sterile: No [EUDAMED]
- Sterilise before use: No [EUDAMED]
- Implantable: No [EUDAMED]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Measuring function: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]

## Source and citation

- Cite as: Aerobika, Trudell Medical International. deviCERTS medical device catalogue. https://devicerts.com/devices/aerobika-110501 (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-25
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/aerobika-110501.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/aerobika-110501
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.