Data / Medical devices / United States / Sanuwave, Inc.
Sanuwave, Inc.: FDA-registered device maker in Eden Prairie, MN, United States, 1 510(k) clearance
Sanuwave, Inc. is registered with the FDA (registration 1062240) in Eden Prairie, MN, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 13, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1062240
- FEI number
- 3006261799
- Address
- 9600 W 76th St, Eden Prairie, MN, United States, 55344
- Owner or operator
- SANUWAVE, INC. (9083571)
- Roles
- Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- December 5, 2008
- Registered through
- 2026
- Brand names listed
- EvoTrode, EvoTron, PACE Applicator for orthoPACE, Profile by SANUWAVE, UltraMIST System, orthoPACE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Shock-Wave, For Pain Relief | NBN | 3 | Manufacturer for export | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Wound Cleaner, Ultrasound | NRB | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 13, 2014 | K140782 | ULTRAMIST SYSTEM, ULTRAMIST GENERATOR, ULTRAMIST TREATMENT WAND, ULTRAMIST APPLICATOR | NRB | Substantially Equivalent | Celleration, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Generator, Shock-Wave, For Pain Relief
- All makers of Massager, Therapeutic, Electric
- All makers of Wound Cleaner, Ultrasound
Updated August 13, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.