sam X1 SA551

GUDID 00857599005202

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

Physical therapy ultrasound system

• Primary Device ID: 00857599005202
• NIH Device Record Key: cf21f568-6a77-4025-b02f-26356f5326a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: sam X1
• Version Model Number: SA551
• Catalog Number: SA551
• Company DUNS: 080128497
• Company Name: ZETROZ SYSTEMS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857599005202 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211513

FDA Product Code

• PFW: Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-07
• Device Publish Date: 2022-09-29

Devices Manufactured by ZETROZ SYSTEMS, LLC

• 00857599005172 - sam(R) Advanced Gel Capture Patch: 2024-10-18 coupling patch for use with sam wearable ultrasound device
• 00857599005165 - sam(R) Advanced Gel Capture Patch: 2024-10-18 coupling patch for use with sam wearable ultrasound device
• 00857599005202 - sam X1: 2022-10-07The 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.
• 00857599005202 - sam X1: 2022-10-07 The sustained acoustic medicine, (sam® X1) long-duration ultrasound device is used in the treatment of musculoskeletal injuries
• 00857599005196 - sam 2.0 Long Duration Ultrasound Device for Home Use: 2021-12-08 The sustained acoustic medicine, (sam® 2.0) long-duration ultrasound device is intended for the treatment of musculoskeletal in
• 00857599005073 - sam: 2018-07-06 wearable therapeutic ultrasound
• 00857599005097 - sam coupling patch: 2018-07-06 coupling patch for use with sam wearable ultrasound device