ELECTROMED, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2134852	3003007907	ELECTROMED, INC.	1	N	2026-01-01	502 SIXTH AVE. N.W. NEW PRAGUE MN US 56071

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
55198	1045156169	K222496	Electromed SmartVest Airway Clearance System	BYI	2022-11-18
55198	1277234526	K132794	SMARTVEST AIRWAY CLEARANCE SYSTEM	BYI	2013-12-19
55198	1797168625	K053248	SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL	BYI	2005-12-01
55198	1076127913	K040367	MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ	BYI	2004-04-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
BYI	4	2022-11-18

PMN#

Electromed SmartVest Airway Clearance System
2022-11-18
Electromed, Inc.
SMARTVEST AIRWAY CLEARANCE SYSTEM
2013-12-19
ELECTROMED, INC.
SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL
2005-12-01
ELECTROMED, INC.
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ
2004-04-07
ELECTROMED, INC.
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
1999-06-01
ELECTROMED, INC.

GUDID#

SmartVest - Long term use (LTU) connecting hose
ELECTROMED, INC.
2025-07-02
SmartVest - Electromed SmartVest Clearway Air Pulse Generator, refurbished
ELECTROMED, INC.
2025-03-19
SmartVest - Electromed SmartVest Clearway Air Pulse Generator Demo
ELECTROMED, INC.
2025-01-21
SmartVest - Electromed SmartVest Clearway Air Pulse Generator Eval
ELECTROMED, INC.
2025-01-21
SmartVest - SmartVest O-Ring kit - Black
ELECTROMED, INC.
2023-07-31
Smartvest - Electromed SmartVest Clearway-I Air Pulse Generator - Refurbished
ELECTROMED, INC.
2023-07-05
SmartVest - Electromed SmartVest Mobile Pedestal - Clearway
ELECTROMED, INC.
2023-07-05
Smartvest - Electromed SmartVest Clearway Air Pulse Generator
ELECTROMED, INC.
2023-02-17
Smartvest - Electromed SmartVest Clearway-I Air Pulse Generator
ELECTROMED, INC.
2023-02-17
SmartVest - Mobile Pedestal - SQL®
ELECTROMED, INC.
2016-09-16
SmartVest - SQL® Replacement Foot Kit
ELECTROMED, INC.
2019-03-28
SmartVest - LTU SmartVest® – Child S-Small (Ginkgo)
ELECTROMED, INC.
2016-06-30
SmartVest - LTU SmartVest® – Child S-Small (Pink)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child S-Small (Teal)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child S-Small (Yellow)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child S-Small (Purple)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child S-Small (Red)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child S-Small (Blue)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Small (Teal)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Small (Yellow)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Small (Purple)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Small (Red)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Small (Blue)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Small (Pink)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Small (Ginkgo)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Medium (Teal)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Medium (Yellow)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Medium (Purple)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Medium (Red)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Medium (Blue)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Medium (Pink)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Medium (Ginkgo)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Large (Teal)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Large (Yellow)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Large (Purple)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Large (Red)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Large (Blue)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Large (Pink)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Child Large (Ginkgo)
ELECTROMED, INC.
2016-09-16
SmartVest - LTU SmartVest® – Adult Small (Teal)
ELECTROMED, INC.
2016-09-16

172 records. Showing 1-40. Next