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ZetrOZ Systems

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30107659753010765975ZetrOZ Systems1N2026-01-0156 Quarry Rd Trumbull CT US 06611

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1683161178807178K260076SAM 3.0 Multi-Hour Continuous Ultrasound DevicePFW2026-04-28
1683161808848140K223019sam 2.0 Long Ultrasound DevicePFW2023-06-23
1683161779950135K211513sam X1 Long Duration Ultrasound DevicePFW2021-08-18
1683161234438156K191568sam 2.0 Long Duration Ultrasound SystemPFW2020-03-06
1683162071618375K130978ZTX ULTRASONIC DIATHERMY DEVICEPFW2013-11-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PFW52026-04-28

PMN#

GUDID#

sam 2.0 OA multi-hour continuous ultrasound device for home use - 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.

ZETROZ SYSTEMS, LLC

2026-04-07

sam X1 - The sustained acoustic medicine, (sam® X1) long-duration ultrasound device is used in the treatment of musculoskeletal injuries and pain relief. sam® X1 is the first wire-free option to deliver continuous wave, high-frequency sustained acoustic medicine (3MHz) into deep tissue resulting in improved circulation and nutrient transfer into the injured soft-tissue for multiple hours each day. This sam® mechanism of action improves and accelerates soft tissue healing for tendinopathies, meniscus injuries, osteoarthritis, joint injuries (knee, shoulder, elbow, wrist) and tissue compromised by repetitive and/or overuse injuries. For pain management secondary to injury, sam® X1 provides localized, non-systemic pain management and is an appropriate treatment alternative for prescribers seeking to avoid the systemic effects of NSAIDs and opiates. sam® X1 is FDA cleared and indicated for prescription home-use, and easily accommodates self-administered treatment by applying the treatment applicator with a hypoallergenic single use pre-filled coupling patch over the soft-tissue injury and activating the battery-operated power controller for autonomous therapeutic delivery.

ZETROZ SYSTEMS, LLC

2022-09-29

sam 2.0 Long Duration Ultrasound Device for Home Use - The sustained acoustic medicine, (sam® 2.0) long-duration ultrasound device is intended for the treatment of musculoskeletal injuries and pain relief. sam® 2.0 delivers continuous wave, high-frequency sustained acoustic medicine (3MHz) into deep tissue for up to 4 hours, resulting in improved circulation and nutrient transfer into the injured soft-tissue for multiple hours each day. This sam® mechanism of action improves and accelerates soft tissue healing for tendinopathies, meniscus injuries, osteoarthritis, joint injuries (knee, shoulder, elbow, wrist) and tissue compromised by repetitive and/or overuse injuries. For pain management secondary to injury, sam® 2.0 provides localized, non-systemic pain management and is an appropriate treatment alternative for prescribers seeking to avoid the systemic effects of NSAIDs and opiates. sam® 2.0 is FDA cleared and indicated for prescription home-use, and easily accommodates self-administered treatment by applying the treatment applicator with a hypoallergenic single use pre-filled coupling patch over the soft-tissue injury and activating the battery-operated power controller for autonomous therapeutic delivery.

ZETROZ SYSTEMS, LLC

2021-11-30