FDA.reportPublic FDA data

SANUWAVE, INC.

Matched from indexed company URL: Sanuwave, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10622403006261799SANUWAVE, INC.1N2026-01-019600 W 76th St Eden Prairie MN US 55344

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00812265010225dermaPACE System (Console with applicator) - The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.678-578-0108order@sanuwave.con
00812265010287Profile Console - Profile provides mechanically assisted deep soft tissue massage through a novel form of acoustic enerfy called Diffused Acostic Pressure.678-578-0108order@sanuwave.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
663341120700699P990086HEALTHTRONICS OSSATRONNBN2000-10-12
663341591604331K140782ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATORNRB2014-08-13
663342022872373DEN160037dermaPACE SystemPZL2017-12-28
663341657146858
663341761603255

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PZL12017-12-28
NRB12014-08-13
NBN12000-10-12

PMA#

GUDID#