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sam 2.0 Long Duration Ultrasound Device for Home Use

FDA UDI

Class II (US FDA UDI)

by ZetrOZ Systems

Identity

Trade Name
sam 2.0 Long Duration Ultrasound Device for Home Use FDA UDI
Generic Name
Physical therapy ultrasound system FDA UDI
Device Name
The 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. FDA UDI
Model / Reference
SA271 FDA UDI
Description
The 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. FDA UDI

Identifiers

Primary DI / UDI-DI
00857599005196 FDA UDI
510(k) Number
K191568 FDA UDI
FDA Product Code
PFW FDA UDI
GMDN Term
Physical therapy ultrasound system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5300 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Physical therapy ultrasound system

sam 2.0 Long Duration Ultrasound Device for Home Use by ZetrOZ Systems — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Physical therapy ultrasound system.

Cleared under the same submission

K191568 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ZetrOZ Systems

Sources (1)

  • FDA UDI c245efeb-4d97-4303-8597-7528575521b3 34 fields · synced Jun 1, 2026