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510(k) K063645

FREQUENCER, MODEL 1001 by Dymedso, Inc. — Product Code BYI

K063645 is an FDA 510(k) premarket notification submitted by Dymedso, Inc. for the device "FREQUENCER, MODEL 1001". The FDA issued a decision of Substantially Equivalent on March 15, 2007. 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
March 15, 2007
Date Received
December 7, 2006
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)
  • K100749 — FREQUENCER MODEL V2X (August 31, 2010)

Other clearances for product code BYI

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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