Cheen Houng Ent. Co., Ltd.
Country not established FDA
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Cheen Houng Ent. Co., Ltd. makes
Cheen Houng Ent. Co., Ltd. manufactures manual resuscitation devices, including portable resuscitators like the Y2000 Pocket Rescue and Y2000 Manual Resuscitator (models RUGU01/RUG02 and RUGH01/RUGH02), as well as a PEEP (Positive End-Expiratory Pressure) valve rated for 0–20 cm H₂O. Their product line also includes a compact resuscitator (PMX Compact Resuscitator) and a device for assisted ventilation (Breath Shake).
These devices are classified under FDA’s Class I and Class II categories and are listed via the 510(k) pathway. The company’s products are regulated under U.S. medical device laws, with records available in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Y2000 Pocket Rescue Ref K010191
510(k) 510(k)Breath Shake Ref K121587
510(k) 510(k)0-20 Cm H20 Peep Valve Ref K981415
510(k) 510(k)Pmx Compact Resucitator Ref K021390
510(k) 510(k)Pocket Rescue Ref K970688
510(k) 510(k)- 510(k) 510(k)
FDA establishments
- Cheen Houng Ent. Co. Ltd. SHULIN Taipei · TW FEI 3002806674
Frequently asked questions
How many devices does Cheen Houng Ent. Co., Ltd. have in the registry?
The registry currently lists 6 devices for Cheen Houng Ent. Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cheen Houng Ent. Co., Ltd.'s devices?
Among its 6 most recently registered devices, Cheen Houng Ent. Co., Ltd. has devices listed in FDA 510(k) (6 devices).
What risk classes do Cheen Houng Ent. Co., Ltd.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Cheen Houng Ent. Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cheen Houng Ent. Co., Ltd. in the registry?
The most recently registered devices listed for Cheen Houng Ent. Co., Ltd. include Y2000 POCKET RESCUE, BREATH SHAKE, 0-20 CM H20 PEEP VALVE and PMX COMPACT RESUCITATOR.
Which FDA establishments are linked to Cheen Houng Ent. Co., Ltd.?
1 FDA establishment is linked to Cheen Houng Ent. Co., Ltd. in the registry; they are listed on the company page.