ZETROZ SYSTEMS, LLC

Address:56 Quarry Rd,Trumbull,CT,06611,US

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- Catalog Number :

Device Description : wearable therapeutic ultrasound

Device Class : 2

Duns Number: 080128497

Premarket Exempt : No

Product Code : PFW

Prescription Use : Yes

Device Count : 1

Device Description : coupling patch for use with sam wearable ultrasound device

Device Class :

Duns Number: 080128497

Premarket Exempt : No

Product Code : PFW

Prescription Use : Yes

Device Count : 10

Device Description : The sustained acoustic medicine, (sam® 2.0) long-duration ultrasound device is i 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.

Device Class : 2

Duns Number: 080128497

Premarket Exempt : No

Product Code : PFW

Prescription Use : Yes

Device Count : 1

- Catalog Number : SA551

Device Description : The sustained acoustic medicine, (sam® X1) long-duration ultrasound device is us 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.

Device Class : 2

Duns Number: 080128497

Premarket Exempt : No

Product Code : PFW

Prescription Use : Yes

Device Count : 1