| Primary Device ID | 00857599005196 |
| NIH Device Record Key | c245efeb-4d97-4303-8597-7528575521b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | sam 2.0 Long Duration Ultrasound Device for Home Use |
| Version Model Number | SA271 |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00857599005196 [Primary] |
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-12-08 |
| Device Publish Date | 2021-11-30 |
| 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 | 2021-12-08The 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. |
| 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 |