SANUWAVE, INC.

FDA Device Registration & Listing · Eden Prairie, MN, US · Registration 1062240

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1062240
FEI Number
3006261799
Entity Name
SANUWAVE, INC.
City/State/Country
Eden Prairie, MN, US
Establishment Address
9600 W 76th St, Eden Prairie, MN 55344, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
SANUWAVE, INC. (Owner Number: 9083571)
Owner / Operator Contact Address
9600 W 76th St, Eden Prairie, MN 55344, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K140782
PMA Number
N/A

All Registered Proprietary Names

orthoPACE PACE Applicator for orthoPACE EvoTron EvoTrode Profile by SANUWAVE UltraMIST System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NBN Generator, Shock-Wave, For Pain Relief Unknown Class 3 N/A 2009-03-05
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2008-12-05
NRB Wound Cleaner, Ultrasound General, Plastic Surgery Class 2 878.4410 2020-09-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SANUWAVE, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1062240. Last updated year: 2026. Please use registration number 1062240 when referencing this establishment in official correspondence.
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