Sam 2.0 Long Duration Ultrasound Device for Home Use

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,…

Registry build 21.09.26

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.

2manufacturers in China registered for this device type
1catalogue number
5510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code PFW
Manufacturer City Province Registered as Device types
Grandway Technology (Shenzhen) Limited Shenzhen Guangdong Contract manufacturer 6
JKH Health Co., Ltd. Dongguan Guangdong Contract manufacturer 22

Record

Regulatory record for sam 2.0 Long Duration Ultrasound Device for Home Use
Listed by ZetrOZ Systems, United States
FDA product code PFW
Device type Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
Device class Class 2
Regulation 21 CFR 890.5300
Establishment Manufacturer
510(k) K191568
Record published 2021-11-30

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries expiry date, serial number

Catalogue Numbers

Catalogue numbers for sam 2.0 Long Duration Ultrasound Device for Home Use
Catalogue number Size Status
SA271 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
sam(R) Advanced Gel Capture Patch ZetrOZ Systems 2
Hill Laboratories Company Syrma Johari MedTech Limited 1
Reusable Patch Nanovibronix, Ltd. 1
PainShield Plus 3.0 Driver Nanovibronix, Ltd. 1
sam coupling patch ZetrOZ Systems 1
PainShield Patch Nanovibronix, Ltd. 1
sam X1 ZetrOZ Systems 1
PainShield Plus Actuator Nanovibronix, Ltd. 1
PainShield MD Kit Nanovibronix, Ltd. 1
sam 2.0 OA multi-hour continuous ultrasound device for home use ZetrOZ Systems 1
PainShield 3.0 Driver Nanovibronix, Ltd. 1
sam ZetrOZ Systems 1

Showing 12 of 19. All products under Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K260076 2026-04-28
K233210 2023-10-25
K223019 2023-06-23
K211513 2021-08-18
K191568 2020-03-06

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer