Electromed Inc

FDA Filings

This page includes the latest FDA filings for Electromed Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USA

AMEX

ELMD

DUNS 036514250

FDA Registration(s)

• Registration Number: 2134852
• FEI Number: 3003007907
• Name: ELECTROMED, INC.
• Owner & Operator: ELECTROMED, INC.
• Contact Address: 502 SIXTH AVE., NW --; New Prague MN 56071 US
• Official Correspondent:
  • Gregory A Spurlock
  • x-952-7580328-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 502 SIXTH AVE. N.W. ; NEW PRAGUE, MN 56071 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID B102090170S0100 ELECTROMED, INC.	SmartVest SMARTVEST-OR	2023-08-08
GUDID B102125011S0100 ELECTROMED, INC.	SmartVest CLEARWAY-PED	2023-07-13
GUDID B102125003S0210 ELECTROMED, INC.	Smartvest Clearway-IR	2023-07-13
GUDID B102125003S0200 ELECTROMED, INC.	Smartvest Clearway-I Air Pulse Generator	2023-02-27
GUDID B102125003S0100 ELECTROMED, INC.	Smartvest Clearway Air Pulse Generator	2023-02-27
PMN K222496 Electromed, Inc.	Electromed SmartVest Airway Clearance System	2022-11-18
GUDID B102090766S0100 ELECTROMED, INC.	SmartVest SQL-FOOT-KIT	2019-12-11
GUDID B102060710S2070 ELECTROMED, INC.	SmartVest SV-44-AL-GC	2019-12-11
GUDID B102060710S2060 ELECTROMED, INC.	SmartVest SV-40-AM-GC	2019-12-11
GUDID B102060710S2050 ELECTROMED, INC.	SmartVest SV-36-AS-GC	2019-12-11
GUDID B102060710S2040 ELECTROMED, INC.	SmartVest SV-32-CL-GC	2019-12-11
GUDID B102060710S2030 ELECTROMED, INC.	SmartVest SV-28-CM-GC	2019-12-11
GUDID B102060710S2020 ELECTROMED, INC.	SmartVest SV-24-CS-GC	2019-12-11
GUDID B102060710S2010 ELECTROMED, INC.	SmartVest SV-20-SS-GC	2019-12-11
GUDID B102060710S0180 ELECTROMED, INC.	SmartVest SV-48-AX-BK	2019-12-11
GUDID B102060710S0170 ELECTROMED, INC.	SmartVest SV-44-AL-BK	2019-12-11
GUDID B102060710S0160 ELECTROMED, INC.	SmartVest SV-40-AM-BK	2019-12-11
GUDID B102060710S0150 ELECTROMED, INC.	SmartVest SV-36-AS-BK	2019-12-11
GUDID B102060710S0140 ELECTROMED, INC.	SmartVest SV-32-CL-BK	2019-12-11
GUDID B102060710S0130 ELECTROMED, INC.	SmartVest SV-28-CM-BK	2019-12-11
GUDID B102060710S0120 ELECTROMED, INC.	SmartVest SV-24-CS-BK	2019-12-11
GUDID B102060710S0110 ELECTROMED, INC.	SmartVest SV-20-SS-BK	2019-12-11
GUDID B102060210S0100 ELECTROMED, INC.	SmartVest SV-EXT	2019-12-11
GUDID B102060171S0700 ELECTROMED, INC.	SmartVest I-VAX-48	2019-12-11
GUDID B102060171S0600 ELECTROMED, INC.	SmartVest I-VAL-44	2019-12-11
GUDID B102060171S0500 ELECTROMED, INC.	SmartVest I-VAM-40	2019-12-11
GUDID B102060171S0400 ELECTROMED, INC.	SmartVest I-VAS-36	2019-12-11
GUDID B102060171S0300 ELECTROMED, INC.	SmartVest I-VCL-32	2019-12-11
GUDID B102060171S0200 ELECTROMED, INC.	SmartVest I-VCM-28	2019-12-11
GUDID B102060171S0100 ELECTROMED, INC.	SmartVest I-VCS-24	2019-12-11
GUDID B102060171S0050 ELECTROMED, INC.	SmartVest I-VSS-20	2019-12-11
GUDID B102060154S0105 ELECTROMED, INC.	SmartVest SW-MULTI-5	2019-12-11
GUDID B102060145S1800 ELECTROMED, INC.	SmartVest LTUSW-54/66	2019-12-11
GUDID B102060145S1700 ELECTROMED, INC.	SmartVest LTUSW-44/54	2019-12-11
GUDID B102060145S1600 ELECTROMED, INC.	SmartVest LTUSW-36/44	2019-12-11
GUDID B102060145S1500 ELECTROMED, INC.	SmartVest LTUSW-30/36	2019-12-11
GUDID B102060145S1400 ELECTROMED, INC.	SmartVest LTUSW-25/30	2019-12-11
GUDID B102060145S1300 ELECTROMED, INC.	SmartVest LTUSW-17/25	2019-12-11
GUDID B102060145S0800 ELECTROMED, INC.	SmartVest SW-54/66-1	2019-12-11
GUDID B102060145S0700 ELECTROMED, INC.	SmartVest SW-44/54-1	2019-12-11
GUDID B102060145S0600 ELECTROMED, INC.	SmartVest SW-36/44-1	2019-12-11
GUDID B102060145S0500 ELECTROMED, INC.	SmartVest SW-30/36-1	2019-12-11
GUDID B102060145S0400 ELECTROMED, INC.	SmartVest SW-25/30-1	2019-12-11
GUDID B102060145S0300 ELECTROMED, INC.	SmartVest SW-17/25-1	2019-12-11
GUDID B102060145S0200 ELECTROMED, INC.	SmartVest SW-15/25-1	2019-12-11
GUDID B102060078S0760 ELECTROMED, INC.	SmartVest SV-48-AX-GK	2019-12-11
GUDID B102060078S0750 ELECTROMED, INC.	SmartVest SV-48-AX-PK	2019-12-11
GUDID B102060078S0740 ELECTROMED, INC.	SmartVest SV-48-AX-BU	2019-12-11
GUDID B102060078S0730 ELECTROMED, INC.	SmartVest SV-48-AX-RD	2019-12-11
GUDID B102060078S0720 ELECTROMED, INC.	SmartVest SV-48-AX-PP	2019-12-11
GUDID B102060078S0710 ELECTROMED, INC.	SmartVest SV-48-AX-YL	2019-12-11
GUDID B102060078S0700 ELECTROMED, INC.	SmartVest SV-48-AX	2019-12-11
GUDID B102060078S0660 ELECTROMED, INC.	SmartVest SV-44-AL-GK	2019-12-11
GUDID B102060078S0650 ELECTROMED, INC.	SmartVest SV-44-AL-PK	2019-12-11
GUDID B102060078S0640 ELECTROMED, INC.	SmartVest SV-44-AL-BU	2019-12-11
GUDID B102060078S0630 ELECTROMED, INC.	SmartVest SV-44-AL-RD	2019-12-11
GUDID B102060078S0620 ELECTROMED, INC.	SmartVest SV-44-AL-PP	2019-12-11
GUDID B102060078S0610 ELECTROMED, INC.	SmartVest SV-44-AL-YL	2019-12-11
GUDID B102060078S0600 ELECTROMED, INC.	SmartVest SV-44-AL	2019-12-11
GUDID B102060078S0560 ELECTROMED, INC.	SmartVest SV-40-AM-GK	2019-12-11
GUDID B102060078S0550 ELECTROMED, INC.	SmartVest SV-40-AM-PK	2019-12-11
GUDID B102060078S0540 ELECTROMED, INC.	SmartVest SV-40-AM-BU	2019-12-11
GUDID B102060078S0530 ELECTROMED, INC.	SmartVest SV-40-AM-RD	2019-12-11
GUDID B102060078S0520 ELECTROMED, INC.	SmartVest SV-40-AM-PP	2019-12-11
GUDID B102060078S0510 ELECTROMED, INC.	SmartVest SV-40-AM-YL	2019-12-11
GUDID B102060078S0500 ELECTROMED, INC.	SmartVest SV-40-AM	2019-12-11
GUDID B102060078S0460 ELECTROMED, INC.	SmartVest SV-36-AS-GK	2019-12-11
GUDID B102060078S0450 ELECTROMED, INC.	SmartVest SV-36-AS-PK	2019-12-11
GUDID B102060078S0440 ELECTROMED, INC.	SmartVest SV-36-AS-BU	2019-12-11
GUDID B102060078S0430 ELECTROMED, INC.	SmartVest SV-36-AS-RD	2019-12-11
GUDID B102060078S0420 ELECTROMED, INC.	SmartVest SV-36-AS-PP	2019-12-11
GUDID B102060078S0410 ELECTROMED, INC.	SmartVest SV-36-AS-YL	2019-12-11
GUDID B102060078S0400 ELECTROMED, INC.	SmartVest SV-36-AS	2019-12-11
GUDID B102060078S0360 ELECTROMED, INC.	SmartVest SV-32-CL-GK	2019-12-11
GUDID B102060078S0350 ELECTROMED, INC.	SmartVest SV-32-CL-PK	2019-12-11
GUDID B102060078S0340 ELECTROMED, INC.	SmartVest SV-32-CL-BU	2019-12-11
GUDID B102060078S0330 ELECTROMED, INC.	SmartVest SV-32-CL-RD	2019-12-11
GUDID B102060078S0320 ELECTROMED, INC.	SmartVest SV-32-CL-PP	2019-12-11
GUDID B102060078S0310 ELECTROMED, INC.	SmartVest SV-32-CL-YL	2019-12-11
GUDID B102060078S0300 ELECTROMED, INC.	SmartVest SV-32-CL	2019-12-11
GUDID B102060078S0260 ELECTROMED, INC.	SmartVest SV-28-CM-GK	2019-12-11
GUDID B102060078S0250 ELECTROMED, INC.	SmartVest SV-28-CM-PK	2019-12-11
GUDID B102060078S0240 ELECTROMED, INC.	SmartVest SV-28-CM-BU	2019-12-11
GUDID B102060078S0230 ELECTROMED, INC.	SmartVest SV-28-CM-RD	2019-12-11
GUDID B102060078S0220 ELECTROMED, INC.	SmartVest SV-28-CM-PP	2019-12-11
GUDID B102060078S0210 ELECTROMED, INC.	SmartVest SV-28-CM-YL	2019-12-11
GUDID B102060078S0200 ELECTROMED, INC.	SmartVest SV-28-CM	2019-12-11
GUDID B102060078S0160 ELECTROMED, INC.	SmartVest SV-24-CS-GK	2019-12-11
GUDID B102060078S0150 ELECTROMED, INC.	SmartVest SV-24-CS-PK	2019-12-11
GUDID B102060078S0140 ELECTROMED, INC.	SmartVest SV-24-CS-BU	2019-12-11
GUDID B102060078S0130 ELECTROMED, INC.	SmartVest SV-24-CS-RD	2019-12-11
GUDID B102060078S0120 ELECTROMED, INC.	SmartVest SV-24-CS-PP	2019-12-11
GUDID B102060078S0110 ELECTROMED, INC.	SmartVest SV-24-CS-YL	2019-12-11
GUDID B102060078S0100 ELECTROMED, INC.	SmartVest SV-24-CS	2019-12-11
GUDID B102060078S0090 ELECTROMED, INC.	SmartVest SV-20-SS-BU	2019-12-11
GUDID B102060078S0080 ELECTROMED, INC.	SmartVest SV-20-SS-RD	2019-12-11
GUDID B102060078S0070 ELECTROMED, INC.	SmartVest SV-20-SS-PP	2019-12-11
GUDID B102060078S0060 ELECTROMED, INC.	SmartVest SV-20-SS-YL	2019-12-11
GUDID B102060078S0050 ELECTROMED, INC.	SmartVest SV-20-SS	2019-12-11
GUDID B102060078S0040 ELECTROMED, INC.	SmartVest SV-20-SS-PK	2019-12-11
GUDID B102060078S0030 ELECTROMED, INC.	SmartVest SV-20-SS-GK	2019-12-11
PMN K132794 | BYI ELECTROMED, INC.	SmartVest	2014-12-15
PMN K132794 | BYI ELECTROMED, INC.	SQL	2014-12-15
PMN K132794 ELECTROMED, INC.	SMARTVEST AIRWAY CLEARANCE SYSTEM	2013-12-19
PMN K053248 ELECTROMED, INC.	SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL	2005-12-01
PMN K040367 ELECTROMED, INC.	MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZ	2004-04-07
PMN K053248 | BYI ELECTROMED, INC.	SmartVest	1999-10-15
PMN K040367 | BYI ELECTROMED, INC.	MedPulse	1999-10-15
PMN K982889 ELECTROMED, INC.	MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000	1999-06-01

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Related Finance Registrations

NCAGE Code	49EZ7	ELECTROMED, INC.
CAGE Code	49EZ7	ELECTROMED, INC.
S.A.M. Registration	49EZ7 [36514250]	ELECTROMED, INC.
SEC	0001173005	ELECTROMED INC
SEC	0001488917	Electromed, Inc.