DEVICE: sam X1 (00857599005202)
Device Identifier (DI) Information
sam X1
SA551
In Commercial Distribution
SA551
ZETROZ SYSTEMS, LLC
SA551
In Commercial Distribution
SA551
ZETROZ SYSTEMS, LLC
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 Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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11248 | Physical therapy ultrasound system |
An assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K211513 | 000 |
Sterilization
Storage and Handling
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No storage/handling found |
Clinically Relevant Size
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No Device Sizes |
Device Record Status
cf21f568-6a77-4025-b02f-26356f5326a5
October 07, 2022
1
September 29, 2022
October 07, 2022
1
September 29, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined