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510(k) K100749

FREQUENCER MODEL V2X by Dymedso, Inc. — Product Code BYI

K100749 is an FDA 510(k) premarket notification submitted by Dymedso, Inc. for the device "FREQUENCER MODEL V2X". The FDA issued a decision of Substantially Equivalent on August 31, 2010. The device falls under product code BYI (Percussor, Powered-Electric), a Class II device regulated under 21 CFR 868.5665. Dymedso, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2010
Date Received
March 16, 2010
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 Dymedso, Inc.

  • K103176 — FREQUENCER (January 26, 2011)
  • K063645 — FREQUENCER, MODEL 1001 (March 15, 2007)

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  • 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