Timewaver Production GmbH

Timewaver Production GmbH specializes in transcutaneous neuromuscular electrical stimulation (TENS) systems for physical therapy. These devices are designed to deliver targeted electrical stimulation to aid in muscle re-education and pain management. Their portfolio includes systems like the Healy and TimeWaver Frequency, which fall under the category of physical therapy TENS systems.

Timewaver Production GmbH is based in the United States. The company’s location is relevant for understanding its regulatory scope and compliance with U.S. medical device regulations.

Timewaver Production GmbH’s devices are listed in the FDA’s 510(k) pre-market submission registry and the FDA’s Unique Device Identifier (UDI) system. These registries track devices that have undergone the required regulatory pathways for Class II classification, ensuring compliance with U.S. medical device regulations.

Timewaver Production GmbH’s devices are classified as Class II under regulatory frameworks. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as TENS systems used in physical therapy.