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 Issuing Agency | Device ID |
---|---|
GS1 | 00857599005202 [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 | 2022-10-07 |
Device Publish Date | 2022-09-29 |
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 |