LungTrainer (MD2 & MD3)

FDA 510(k) K221058 · Lung Trainers, LLC

Substantially Equivalent

510(k) numberK221058

Submission

Device name
LungTrainer (MD2 & MD3)
Applicant
Lung Trainers, LLC
Miami, FL, US
Received
April 11, 2022
Decision date
July 5, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
BWF – Spirometer, Therapeutic (Incentive)
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5690
Specialty
Anesthesiology

Other 510(k)s with product code BWF

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K241152InSeeBWF · Traditional Tidal Medical Technologies, LLC08/21/2025SE
K233855AllPEPBWF · Traditional Enchant Tek Co. , Ltd.02/02/2024SE
K222018Breathe+BWF · Traditional Peep Medical, LLC Dba Go2 Devices06/02/2023SE
K220565Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWF · Traditional Medline Industries, Inc.10/25/2022SE
K203378PulsehalerBWF · Traditional Respinova, Ltd.03/31/2021SE
K192000D R Burton OxyPAPBWF · Traditional D R Burton Healthcare, LLC02/19/2020SE
K181660Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional Smiths Medical10/24/2019SE
K183108Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional Trudell Medical International08/16/2019SE
K182847Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional Teleflexmedical, Inc.07/01/2019SE
K173918VersaPAP Positive Airway Pressure (PAP) DeviceBWF · Traditional Trudell Medical International08/17/2018SE

Questions and answers

When was LungTrainer (MD2 & MD3) cleared by the FDA?

LungTrainer (MD2 & MD3) (K221058) received a 510(k) decision of Substantially Equivalent on July 5, 2023, 450 days after the submission was received.

What is the product code of K221058?

The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.