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510(k) K121587

BREATH SHAKE by Cheen Houng Ent. Co. , Ltd. — Product Code BYI

K121587 is an FDA 510(k) premarket notification submitted by Cheen Houng Ent. Co. , Ltd. for the device "BREATH SHAKE". The FDA issued a decision of Substantially Equivalent on November 22, 2013. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Cheen Houng Ent. Co. , Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2013
Date Received
May 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percussor, Powered-Electric
Device Class
Class II
Regulation Number
868.5665
Review Panel
AN
Submission Type

Other clearances by Cheen Houng Ent. Co. , Ltd.

  • K021390 — PMX COMPACT RESUCITATOR (October 4, 2002)
  • K003927 — Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02 (June 26, 2001)
  • K010191 — Y2000 POCKET RESCUE (March 14, 2001)
  • K981415 — 0-20 CM H20 PEEP VALVE (July 14, 1998)
  • K970688 — POCKET RESCUE (September 26, 1997)

Other clearances for product code BYI

  • K252849 — AffloVest® Mobile Airway Clearance Therapy (April 30, 2026)
  • K250860 — BreatheBand® (Model 1000) (October 2, 2025)
  • K242063 — LibAirty Airway Clearance System (December 19, 2024)
  • K240959 — Respiratory Muscle Trainer (December 18, 2024)
  • K233441 — The Vest APX System (PVAPX1) (March 22, 2024)
  • K222496 — Electromed SmartVest Airway Clearance System (November 18, 2022)
  • K201490 — Electro Flo 6 Airway Clearance System (February 12, 2021)
  • K203209 — AirPhysio Positive Expiratory Pressure (PEP) Device (January 15, 2021)
  • K173603 — Monarch Airway Clearance System (October 24, 2018)
  • K163378 — Monarch Airway Clearance System (March 17, 2017)

FDA data resources