PainShield MD Kit
PainShield MD is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions including pain and soft tissue injuries. The…
PainShield MD is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions including pain and soft tissue injuries. The low intensity and low frequency ultrasound energy is effective within a diameter of 20 cm and a depth of approximately 3 cm.
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 | 2020-12-22 |
| Record revised | 2025-03-21 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
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 |
| 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 |
| 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
| 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.