Basic Information
- Brand Name
- sam 2.0 OA multi-hour continuous ultrasound device for home use
- Primary DI
- 00857599005271
- Version / Model
- SAM 2.0 OA24
- Catalog Number
- OA24
- Company Name
- ZETROZ SYSTEMS, LLC
- Labeler DUNS
- 080128497
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-07
- Public Version
- 1
- Public Version Date
- 2026-04-15
- Public Version Status
- New
- Public Device Record Key
- c3783fb6-4b4e-4f2a-b8d2-eb80a01acaf7
Device Description
Sustained Acoustic Medicine SAM 2.0 OA24 multi-hour continuous ultrasound device is FDA-cleared for prescription home use to apply high-frequency (3MHz), high-dosimetry (1.3W, 18,720J) ultrasonic energy to generate and sustain deep non-thermal (mechanotransducive) and thermal (vigorous diathermy @ 44C) for the relief of pain associated with limited mobility and function related to soft tissue injuries including knee osteoarthritis, chronic myofascial pain, and shoulder, elbow and ankle tendinopathy.
Each system contains 2 autonomous applicators which independently apply divergent beam ultrasound and acoustic streaming to the joint space over a sustained 4-hour period. These are attached to the treatment site with ultrasonic coupling devices to allow for wearability, active daily use, and articulation on the body. The preset frequency, intensity and clinically proven therapeutic parameters cannot be modified by the user. This treatment algorithm provides thermal and mechanical stimulation into deep tissue (5-10 cm), to increase local circulation, stimulate cellular proliferation, improve joint lubricity, reduce inflammation, and relieve pain in the arthritic joint.
SAM represents the convergence of scientific advancements in acoustics, biomechanics and medical technology, delivering a non-invasive, drug-free and targeted treatment for chronic musculoskeletal injuries. Designed for the aging population, taking into consideration thinning and sensitive skin, and ease of daily application and removal, SAM 2.0 OA24 is certified by the U.S. Arthritis Foundation for Ease-of-Use for arthritis patients with chronic joint pain. The basic science, clinical design efforts, human-factor validations, level I clinical studies and regulatory approvals are supported by the National Institutes of Health program wide initiative of Helping to End Opioid Addiction Long-Term® (NIH HEAL) and the National Institutes on Aging research programs for patients with chronic arthritis pain.