PainShield 3.0 Driver
PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area. The user may feel minor warmth at the treatment patch site…
PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area. The user may feel minor warmth at the treatment patch site during the treatment period. PainShield MD should be used under the prescription of a physician or physical therapist. PainShield MD is comprised of two elements: a treatment patch that contains the transducer, which delivers ultrasound waves, and a portable battery-operated driver.
Who Else Makes It
All of them in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| 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
| Listed by | Nanovibronix, Ltd., Israel |
|---|---|
| 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 | Specification developer, Manufacturer |
| Record published | 2023-07-16 |
| Record revised | 2026-05-18 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 40 °C; Storage environment humidity 10 to 80 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3.0 | In distribution |
Same 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 Long Duration Ultrasound Device for Home Use | ZetrOZ Systems | 1 |
| sam 2.0 OA multi-hour continuous ultrasound device for home use | ZetrOZ Systems | 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
| Clearance | Decision date |
|---|---|
| K221210 | 2022-11-23 |
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.