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Frequencer V2X

by Dymedso, Inc.

Frequencer V2X (DYMV2X) is a chest-percussion airway secretion-clearing system (FDA Class II; FDA product code BYI, Percussor, Powered-Electric) made by Dymedso, Inc., cleared under FDA 510(k) K103176 on 26 Jan 2011 and listed in FDA GUDID since 17 Feb 2017 (UDI-DI B401DYMV2X0), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K103176

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB401DYMV2X0 UDI-DI Date17 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103176 Date26 Jan 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103176 decided 26 Jan 2011 Active
  • FDA GUDID UDI-DI B401DYMV2X0 listed 17 Feb 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K103176
  2. Listed FDA GUDID B401DYMV2X0

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Frequencer
Generic name
Chest-percussion airway secretion-clearing system
Model / Ref / Catalog
V2X, DYMV2X
Primary DI / UDI-DI
B401DYMV2X0
510(k) Number
FDA product code
BYI
GMDN term
Chest-percussion airway secretion-clearing system
Device class
Class II
Regulation number
868.5665
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Chest-percussion airway secretion-clearing system

Cleared under the same submission (K103176)

Similar devices

Other devices filed under FDA product code BYI (Percussor, Powered-Electric).

Other devices from Dymedso, Inc.

See all devices from Dymedso, Inc. →

Properties

  • Over-the-counter
  • Serial number
Other properties (13, all answered No)