Home / 510(k) Clearances / K982889

510(k) K982889

MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000 by Electromed, Inc. — Product Code BYI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1999
Date Received
August 17, 1998
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 Electromed, Inc.

  • K222496 — Electromed SmartVest Airway Clearance System (November 18, 2022)
  • K132794 — SMARTVEST AIRWAY CLEARANCE SYSTEM (December 19, 2013)
  • K053248 — SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL (December 1, 2005)
  • K040367 — MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ (April 7, 2004)
  • K990813 — REHCOR (April 12, 1999)

Other clearances for product code BYI

  • 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)
  • K142482 — The Vest Airway Clearance System (May 7, 2015)