sam(R) Advanced Gel Capture Patch
coupling patch for use with sam wearable ultrasound device
2manufacturers in China registered for this device type
2catalogue numbers in this listing
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.
| 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 | 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 | 2024-10-10 |
| Record revised | 2026-03-17 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| UB-14 | 15 | In distribution | |
| UB-14 | 15 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| 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.