BREATH SHAKE— 510(k) K121587

Name: FDA 510(k) clearance K121587
Creator: U.S. Food and Drug Administration
Published: 2013-11-22

Substantially Equivalent

Cheen Houng Ent. Co. , Ltd.

FDA 510(k) clearance K121587 for BREATH SHAKE, Substantially Equivalent on 2013-11-22. Applicant: Cheen Houng Ent. Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Cheen Houng Ent. Co. , Ltd.
Product code: Code BYI
Device class: Class 2
Regulation: 21 CFR 868.5665
Advisory panel: Anesthesiology
Date received: 2012-05-31
Decision date: 2013-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BYI

view all

K252849 — AffloVest® Mobile Airway Clearance Therapy2026-04-30
K250860 — BreatheBand® (Model 1000)2025-10-02
K242063 — LibAirty Airway Clearance System2024-12-19
K240959 — Respiratory Muscle Trainer2024-12-18
K233441 — The Vest APX System (PVAPX1)2024-03-22

More clearances from Cheen Houng Ent. Co. , Ltd.

view all

K021390 — PMX COMPACT RESUCITATOR2002-10-04
K003927 — Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH022001-06-26
K010191 — Y2000 POCKET RESCUE2001-03-14
K981415 — 0-20 CM H20 PEEP VALVE1998-07-14
K970688 — POCKET RESCUE1997-09-26

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.