510(k) K233855
- Device
- AllPEP
- Applicant
- Enchant Tek Co. , Ltd.
- 510(k) number
- K233855
- Product code
- BWF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-02-02
- Date received
- 2023-12-05
- Regulation
- 868.5690
- Classification name
- Spirometer, Therapeutic (Incentive)
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Leonard Ling
- Address
- # 210 Xiangzhong Rd. Dongshan Township Yilan County TW 26950 26950
FDA Registration Numbers#
- 3010272829
- 3003449582
- 1526863
- 1220908
- 3002808458
- 3029871637
- 3000143502
- 3003898360
- 2954963
- 3029706818
- 3023272766
- 1317346
- 3010683054
- 3004748541
- 3012970776
- 3031233007
- 3012329712
- 8044169
- 3030447506
- 3033858988
- 3011088743
- 9612777
- 1024404
- 3030446844
- 2518422
- 1417592
- 3003767629
- 9710567
- 3002797442
- 3003799815
- 3014579161
- 3038562397
- 9617604
- 3012542015
- 8030673
- 3012307300
- 3011137372
- 3012494290
- 3021284283
- 3018783526
- 3031506335
- 3013557562
- 3000126629
- 3020460367
- 3043226252
- 1314417
- 3024987598
- 3004365956
- 2183613
Source Documents#
Other 510(k) Records For Product Code BWF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K241152 | InSee | Tidal Medical Technologies, LLC | 2025-08-21 |
| K221058 | LungTrainer (MD2 & MD3) | Lung Trainers, LLC | 2023-07-05 |
| K222018 | Breathe+ | Peep Medical, LLC Dba Go2 Devices | 2023-06-02 |
| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Medline Industries, Inc. | 2022-10-25 |
| K203378 | Pulsehaler | Respinova, Ltd. | 2021-03-31 |
| K192000 | D R Burton OxyPAP | D R Burton Healthcare, LLC | 2020-02-19 |
| K181660 | Acapella Choice Blue Vibratory PEP Device | Smiths Medical | 2019-10-24 |
| K183108 | Combined Aerobika OPEP and VersaPAP device | Trudell Medical International | 2019-08-16 |
| K182847 | Hudson RCI Voldyne Volumetric Exerciser | Teleflexmedical, Inc. | 2019-07-01 |
| K173918 | VersaPAP Positive Airway Pressure (PAP) Device | Trudell Medical International | 2018-08-17 |
| K172388 | VPOD ITPR | Advanced Circulatory System, A Wholly Owned Subsidiary OF | 2017-12-22 |
| K160837 | MEDINET INCENTIVE SPIROMETERS - RESPIPROGRAM | Medinet Srl | 2017-02-23 |
| K163091 | VibraPEP | Medica Holdings, LLC | 2017-02-21 |
| K160636 | iPEP System and vPEP | D R Burton Healthcare, LLC | 2016-08-03 |
| K150044 | O-PEP | Pari Respiratory Equipment, Inc. | 2016-05-27 |