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510(k) K201490

Electro Flo 6 Airway Clearance System by Med Systems, Inc. — Product Code BYI

K201490 is an FDA 510(k) premarket notification submitted by Med Systems, Inc. for the device "Electro Flo 6 Airway Clearance System". The FDA issued a decision of Substantially Equivalent on February 12, 2021. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Med Systems, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2021
Date Received
June 4, 2020
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 Med Systems, Inc.

  • K031876 — ELECTRO FLO PERCUSSOR, MODEL 5000 (November 21, 2003)
  • K941145 — OXY-GENERATOR (September 27, 1995)
  • K853785 — SERIES 2000 MEDS MASK (December 3, 1985)

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)
  • 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)

FDA data resources