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510(k) K132794

SMARTVEST AIRWAY CLEARANCE SYSTEM by Electromed, Inc. — Product Code BYI

K132794 is an FDA 510(k) premarket notification submitted by Electromed, Inc. for the device "SMARTVEST AIRWAY CLEARANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on December 19, 2013. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Electromed, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2013
Date Received
September 6, 2013
Clearance Type
Special
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 Electromed, Inc.

  • K222496 — Electromed SmartVest Airway Clearance System (November 18, 2022)
  • K053248 — SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL (December 1, 2005)
  • K040367 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ (April 7, 2004)
  • K982889 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 (June 1, 1999)
  • K990813 — REHCOR (April 12, 1999)

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