Inspiratory/Expiratory Muscle Exercis
FDA 510(k) K840418 · Inspiron Corp.
510(k) numberK840418
Submission
- Device name
- Inspiratory/Expiratory Muscle Exercis
- Applicant
- Inspiron Corp.
Mchenry, IL, US - Received
- January 31, 1984
- Decision date
- February 17, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| 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 |
|---|---|---|
| K860838 | Inspiron Double Swivel Trach AdapterBZA · Traditional | 04/09/1986SE |
| K850346 | Oxygen ConcentratorCAW · Traditional | 02/04/1985SE |
| K843932 | Vapor-Phase Humidifier Sys-AdvancedBTT · Traditional | 10/18/1984SE |
| K840935 | Manual Resuscitation SystemBTM · Traditional | 04/05/1984SE |
| K841158 | Nebulo 28 Nebulizer KitBTT · Traditional | 03/30/1984SE |
| K834290 | Inspiron Liquid Oxygen SystemBYJ · Traditional | 02/04/1984SE |
| K772072 | Manifold & Nebu. for Doub. Line Mach.CAF · Traditional | 11/15/1977SE |
| K772071 | Manifold & Nebu. for Single Line Mach.CAF · Traditional | 11/15/1977SE |
| K772070 | Ventilator Setup, VolumeCAF · Traditional | 11/15/1977SE |
| K772069 | Vol. Ventilator Setup W/Out NebulizerBZO · Traditional | 11/15/1977SE |
Questions and answers
When was Inspiratory/Expiratory Muscle Exercis cleared by the FDA?
Inspiratory/Expiratory Muscle Exercis (K840418) received a 510(k) decision of Substantially Equivalent on February 17, 1984, 17 days after the submission was received.
What is the product code of K840418?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.