SANUWAVE Health, Inc.

SANUWAVE Health, Inc. manufactures wound therapy ultrasound systems and dermatological extracorporeal shock wave therapy systems, including applicators, consoles, and treatment wands. Examples include the dermaPACE Applicator, dermaPACE System (console with applicator), dermaPACE Console, UltraMIST Generator, UltraMIST Treatment Wand, UltraMIST Single Use Applicator, Profile Applicator, and Profile Console. These products are designed for specific therapeutic uses in wound care and dermatology.

SANUWAVE Health, Inc. is based in the United States, as stated in the provided device data. The company’s country of origin is listed as US, which indicates its primary location for operations and regulatory reporting. This information is derived directly from the COMPANY and COUNTRY fields in the data.

SANUWAVE Health, Inc.'s devices are listed in the FDA's Unique Device Identification (fda_udi) system. This is explicitly stated in the LISTED IN field of the provided data. The fda_udi registry is the U.S. Food and Drug Administration’s system for tracking medical devices through unique identifiers, and no other registries are mentioned in the data.

SANUWAVE Health, Inc.'s devices are classified as Class I and Class II medical devices. This classification is specified in the DEVICE CLASSES field of the provided data. Class I devices are subject to general controls, while Class II devices require special controls in addition to general controls, reflecting varying levels of regulatory oversight based on risk. The data does not assign a single class to all devices, indicating a mix across the product line.