Modification to Resqpod Circulatory Enhancer

Q: What is the product code of K033401?

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

FDA 510(k) K033401 · Advanced Circulatory Systems, Inc.

Substantially Equivalent

510(k) numberK033401

Submission

Device name: Modification to Resqpod Circulatory Enhancer
Applicant: Advanced Circulatory Systems, Inc.
Stoughton, WI, US
Received: October 24, 2003
Decision date: November 20, 2003
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary 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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K241152	InSeeBWF · Traditional	Tidal Medical Technologies, LLC	08/21/2025SE
K233855	AllPEPBWF · Traditional	Enchant Tek Co. , Ltd.	02/02/2024SE
K221058	LungTrainer (MD2 & MD3)BWF · Traditional	Lung Trainers, LLC	07/05/2023SE
K222018	Breathe+BWF · Traditional	Peep Medical, LLC Dba Go2 Devices	06/02/2023SE
K220565	Hudson RCI Triflo II Incentive Deep Breathing ExerciserBWF · Traditional	Medline Industries, Inc.	10/25/2022SE
K203378	PulsehalerBWF · Traditional	Respinova, Ltd.	03/31/2021SE
K192000	D R Burton OxyPAPBWF · Traditional	D R Burton Healthcare, LLC	02/19/2020SE
K181660	Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional	Smiths Medical	10/24/2019SE
K183108	Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional	Trudell Medical International	08/16/2019SE
K182847	Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional	Teleflexmedical, Inc.	07/01/2019SE

More from Teleflexmedical, Inc.

510(k)	Device	Decision
K070490	Cirqlator Intrathoracic Pressure Regulator (Itpr)BWF · Traditional	06/20/2007SE
K040084	Lifestyle Circulatory EnhancerBWF · Abbreviated	04/07/2004SE

Questions and answers

When was Modification to Resqpod Circulatory Enhancer cleared by the FDA?

Modification to Resqpod Circulatory Enhancer (K033401) received a 510(k) decision of Substantially Equivalent on November 20, 2003, 27 days after the submission was received.

What is the product code of K033401?

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