sam X1 - The sustained acoustic medicine, (sam® X1) - ZETROZ SYSTEMS, LLC

Duns Number:080128497

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

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More Product Details

Catalog Number

SA551

Brand Name

sam X1

Version/Model Number

SA551

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K211513

Product Code Details

Product Code

PFW

Product Code Name

Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

Device Record Status

Public Device Record Key

cf21f568-6a77-4025-b02f-26356f5326a5

Public Version Date

October 07, 2022

Public Version Number

1

DI Record Publish Date

September 29, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZETROZ SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3