StemWave® Systems
Built on a Shared Acoustic Architecture
StemWave® develops non-invasive acoustic medical devices engineered for specific clinical applications. While each device is regulated independently according to its intended use, all StemWave systems are built on PACE® Technology, a common acoustic architecture designed to control how mechanical energy is generated, shaped, and delivered into tissue. PACE® Technology provides the foundational energy control layer across StemWave devices. Clinical indications, labeling, and regulatory status are specific to each system and are governed independently.
Shared Architecture
PACE® Technology
PACE® Technology is the engineered acoustic foundation underlying StemWave systems. It is designed to provide:
Controlled acoustic energy generation
Consistent energy delivery across treatment sessions
Adjustable depth and focal characteristics
Non-invasive mechanical stimulation of tissue
PACE® Technology defines how energy is delivered. Each device defines where and why it is used according to its FDA-cleared or FDA-listed indications.
OrthoPACE®
Acoustic Therapy System for Musculoskeletal Applications
Regulatory Status
FDA Classification: Class I
FDA Status: Listed
Current Indications:
Temporary relief of minor aches and pains
Temporary increase in local blood circulation
Activation of connective tissue
Device Overview
OrthoPACE® is a non-invasive acoustic therapy system designed specifically for orthopedic and musculoskeletal environments. The system leverages PACE® Technology to deliver controlled mechanical energy into tissue in support of its listed Class I indications.
The device has been informed by over a decade of acoustic research and is engineered for clinical workflows commonly found in orthopedic, sports medicine, and rehabilitation settings.
Regulatory Notice
OrthoPACE® is currently preparing for Class ll filing. Until additional clearance is obtained, the system is marketed and distributed exclusively under its existing FDA Class I listing and must be used in accordance with current labeling.
DermaPACE®
Focused Acoustic Shockwave System for Chronic Wound Care
Regulatory Status
FDA Classification: Class I
FDA Status: 510(k) Cleared
Current Indications:
Treatment of chronic diabetic foot ulcers
Device Overview
DermaPACE® is a focused acoustic shockwave system cleared by the FDA for the treatment of chronic diabetic foot ulcers. The system delivers controlled acoustic shockwaves intended to activate the body's normal regenerative processes involved in wound healing.
DermaPACE® was the first FDA-cleared shockwave device for wound care, establishing the regulatory foundation for acoustic shockwave therapy in chronic wound management.
Important Regulatory Disclosures
Intended Use
Each StemWave® device is regulated independently and is intended for use only within its FDA-cleared or FDA-listed indications.
PACE® Technology Statement
PACE® Technology is a shared acoustic architecture across StemWave systems. References to PACE® do not imply shared indications or clearance between devices.
Off-Label Use
Nothing on this page is intended to promote or suggest off-label use of any StemWave® device.
Results Disclaimer
Individual clinical outcomes may vary based on patient condition, protocol, and practitioner expertise.
Disclaimer
Individual results may vary. Neither StemWave nor any of its subsidiaries dispense medical advice. The contents of this website do not constitute medical, legal, or any other type of professional advice. Information related to various health, medical, and fitness conditions and their treatment is not meant to be a substitute for the advice provided by a physician or other medical professional. You should not use the information contained herein for diagnosing a health or fitness problem or disease. Rather, please consult your healthcare professional for information on the courses of treatment, if any, which may be appropriate for you. Please consult the User Manual (IFU) and all labeling provided with the product prior to use.