Who else makes this device?

Name: PocketPEP Opep Device w/ T-Piece Adapter & Mouthpiece
Brand: PocketPEP Opep Device w/ T-Piece Adapter & Mouthpiece

Anesthesiology › TherapeuticSpirometer, Therapeutic (Incentive)

PocketPEP Opep Device W/ T-Piece Adapter & Mouthpiece

Single-patient, multi-use device is intended for use as an Oscillating Positive Expiratory Pressure (OPEP) device. The vPEP is intended to be used with patients that can generate an exhaled…

Registry build 21.09.26

Single-patient, multi-use device is intended for use as an Oscillating Positive Expiratory Pressure (OPEP) device. The vPEP is intended to be used with patients that can generate an exhaled flow of 10 liters per minute for 3 → 4 seconds.

3manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong.

Chinese manufacturers registered for FDA product code BWF
Manufacturer	City	Province	Registered as	Device types
Shenzhen Ainengke Electronics Co., Ltd.	Shenzhen	Guangdong	Manufacturer	9
Chinamed Products (China) Ltd.	Gaoyao District	Guangdong	Manufacturer	8
Shenzhen Gwode Technology Co., Ltd.	Shenzhen	Guangdong	Repacker / relabeller	2

Record

Regulatory record for PocketPEP Opep Device w/ T-Piece Adapter & Mouthpiece
Listed by	D R Burton Healthcare, LLC, United States
FDA product code	BWF
Device type	Spirometer, Therapeutic (Incentive)
Device class	Class 2
Regulation	21 CFR 868.5690
Establishment	Specification developer, Manufacturer
510(k)	K160636
Record published	2026-04-28
Record revised	2026-05-21 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, manufacturing date
Packaging	Case of 10

Catalogue Numbers

Catalogue numbers for PocketPEP Opep Device w/ T-Piece Adapter & Mouthpiece
Catalogue number	Size	Status
1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Portex	ICU Medical, Inc	42
Hudson RCI	Teleflex Medical LLC	26
AirLife™	Airlife, Inc.	11
AIM	Vitalograph Ireland Ltd.	9
AirLife	Carefusion	8
Prochamber Assembly	Respironics Respiratory Drug Delivery (Uk), Ltd.	6
Threshold	Respironics Respiratory Drug Delivery (Uk), Ltd.	6
Curaplex	Bound Tree Medical, LLC	5
Hudson RCI	Medline Industries, Inc.	5
VersaPAP™ Positive Airway Pressure Device	Trudell Medical International	4
Curaplex	TRI-Anim Health Services, Inc.	4
Halyard	Owens & Minor Distribution, Inc.	4

Showing 12 of 67. All products under Spirometer, Therapeutic (Incentive)

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K192000	2020-02-19
K160636	2016-08-03

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.