Sanuwave Inc

FDA Filings

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

FDA Registration(s)

• Registration Number: 1062240
• FEI Number: 3006261799
• Name: SANUWAVE, INC.
• Owner & Operator: SANUWAVE, INC.
• Contact Address: 3360 Martin Farm Road Ste 100 ; Suwanee GA 30024 US
• Official Correspondent:
  • PETER - STEGAGNO
  • x-678-6709478-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3360 Martin Farm Rd Ste 100 ; Suwanee, GA 30024 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only
  • Remanufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00812265010348 Sanuwave, Inc.	UltraMIST Single Use Applicator (12 Pack)	2021-02-02
GUDID 00812265010331 Sanuwave, Inc.	UltraMIST Single Use Applicator	2021-02-02
GUDID 00812265010324 Sanuwave, Inc.	UltraMIST Treatment Wand	2021-02-02
GUDID 00812265010317 Sanuwave, Inc.	UltraMIST Generator	2021-02-02
GUDID 00812265010300 Sanuwave, Inc.	Profile Applicator	2021-02-02
GUDID 00812265010294 Sanuwave, Inc.	Profile Applicator	2021-02-02
GUDID 00812265010287 Sanuwave, Inc.	Profile Console	2021-02-02
GUDID 00812265010225 Sanuwave, Inc.	dermaPACE System (Console with applicator)	2021-02-02
GUDID 00812265010218 Sanuwave, Inc.	dermaPACE Console	2021-02-02
GUDID 00812265010201 Sanuwave, Inc.	dermaPACE Applicator	2021-02-02
PMN DEN160037 | PZL SANUWAVE, INC.	dermaPACE Console	2018-02-01
PMN DEN160037 | PZL SANUWAVE, INC.	PACE Applicator for dermaPACE	2018-02-01
De Novo DEN160037 SANUWAVE, INC.	DermaPACE System	2017-12-28
PMN P990086 | NBN SANUWAVE, INC.	Ossaton	2009-03-05
NBN SANUWAVE, INC.	orthoPACE	2009-03-05
NBN SANUWAVE, INC.	PACE Applicator for orthoPACE	2009-03-05
NBN SANUWAVE, INC.	EvoTron	2009-03-05
NBN SANUWAVE, INC.	EvoTrode	2009-03-05
ISA SANUWAVE, INC.	Profile by SANUWAVE	2008-12-05
PMA P990086S004 SANUWAVE, INC.	HEALTHTRONICS OSSATRON	2004-08-06
PMA P990086S003 SANUWAVE, INC.	HEALTHTRONICS OSSATRON	2003-03-14
PMA P990086S001 SANUWAVE, INC.	HEALTHTRONICS OSSATRON	2001-05-01
PMA P990086S002 SANUWAVE, INC.	HEALTHTRONICS OSSATRON	2001-03-30
PMA P990086 SANUWAVE, INC.	HEALTHTRONICS OSSATRON	2000-10-12

Related Finance Registrations

NCAGE Code	4WA79	SANUWAVE, INC.
CAGE Code	4WA79	SANUWAVE, INC.
SEC	0001471736	Sanuwave, Inc. of DELAWARE