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SmartVest SQL-CORD-A

by Electromed, Inc.

SmartVest SQL-CORD-A is a Class II device made by Electromed, Inc., cleared under FDA 510(k) K132794 on 19 Dec 2013 and listed in FDA GUDID since 19 Sep 2016 (UDI-DI B102090504S0100), 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) K132794

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 NumberB102090504S0100 UDI-DI Date19 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK132794 Date19 Dec 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132794 decided 19 Dec 2013 Active
  • FDA GUDID UDI-DI B102090504S0100 listed 19 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132794
  2. Listed FDA GUDID B102090504S0100

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SmartVest
Generic name
Chest-oscillation airway secretion-clearing system generator
Model / Ref / Catalog
SQL-CORD-A
Description
Power Cord - Class II, North America
Primary DI / UDI-DI
B102090504S0100
510(k) Number
FDA product code
BYI
GMDN term
Chest-oscillation airway secretion-clearing system generator
Device class
Class II
Regulation number
868.5665
GUDID distribution status
In Commercial Distribution

Related devices

Category: Chest-oscillation airway secretion-clearing system generator

Cleared under the same submission (K132794)

and 8 more cleared under K132794

Similar devices

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

Other devices from Electromed, Inc.

See all devices from Electromed, Inc. →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)