Product code PFW
- Device name
- Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.5300
- Review panel
- PM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Definition
- Ultrasonic diathermy devices which include stationary applicators enabling hands-free operation.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260076 | SAM 3.0 Multi-Hour Continuous Ultrasound Device | ZetrOZ Systems, LLC | 2026-04-28 |
| K233210 | sam CS Long Duration Ultrasound Device | ZetrOZ Systems, LLC | 2023-10-25 |
| K223019 | sam 2.0 Long Ultrasound Device | ZetrOZ Systems, LLC | 2023-06-23 |
| K221210 | PainShield MD PLUS | Nanovibronix, Inc. | 2022-11-23 |
| K211513 | sam X1 Long Duration Ultrasound Device | ZetrOZ Systems, LLC | 2021-08-18 |
| K191568 | sam 2.0 Long Duration Ultrasound System | ZetrOZ Systems, LLC | 2020-03-06 |
| K130978 | ZTX ULTRASONIC DIATHERMY DEVICE | Zetroz, Inc. | 2013-11-06 |
| K081075 | PAINSHIELD MD | Nano Vibronix , Ltd. | 2008-08-22 |
| K072256 | HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL | Hill Laboratories Co. | 2008-03-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00857599005271 | sam 2.0 OA multi-hour continuous ultrasound device for home use | ZETROZ SYSTEMS, LLC | 2026-04-07 |
| 00850033615593 | echoRx, GUIDE,QUICK START,SNGL,USND | THERMOTEK, INC. | 2026-02-23 |
| 00850033615586 | echoRx, MANUAL, USER, SINGLE, USND | THERMOTEK, INC. | 2026-02-23 |
| 00850033615562 | Echo GEL, TUBE, SINGLE, USND | THERMOTEK, INC. | 2026-02-23 |
| 00850033615555 | Echo ARM STRAP, DEVICE PRTCTR, SNG, USND | THERMOTEK, INC. | 2026-02-23 |
| 00850033615531 | Echo BELT CLIP, DEVICE PRTCTR, SNGL,USND | THERMOTEK, INC. | 2026-02-23 |
| 00850033615517 | Echo POWER SUPPLY, CORD, SINGLE, USND | THERMOTEK, INC. | 2026-02-23 |
| 00850033615500 | Echo APPLICATOR, SINGLE, USND | THERMOTEK, INC. | 2026-02-23 |
| 00850033615487 | Echo Ultra Sound Gel Pod, Single | THERMOTEK, INC. | 2026-02-23 |
| 00850033615425 | Echo Ultra Sound Gel Pods, Carton | THERMOTEK, INC. | 2026-02-23 |
| 00850033615388 | Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXES | THERMOTEK, INC. | 2026-02-23 |
| 00850033615371 | Echo BOX, DRESSING & GEL POD PACK, USND, PRC | THERMOTEK, INC. | 2026-02-23 |
| 00850033615340 | Echo Ultrasound Device (USA) | THERMOTEK, INC. | 2026-02-23 |
| 00850033615289 | Echo Ultrasound Device (USA) | THERMOTEK, INC. | 2026-02-23 |
| 00850033615258 | Echo Ultrasound Device (PRC) | THERMOTEK, INC. | 2026-02-23 |
| 00850033615227 | Echo Ultrasound Device (PRC) | THERMOTEK, INC. | 2026-02-23 |
| 00850033615623 | Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXES | THERMOTEK, INC. | 2026-02-23 |
| 00850033615630 | Echo BOX, DRESSING & GEL POD PACK, USND, USA | THERMOTEK, INC. | 2026-02-23 |
| 00810113682754 | ManaMed Transducer Fixation Strap | Manamed, Inc. | 2025-09-11 |
| 00810113682778 | ManaMed Transducer Holder Patch | Manamed, Inc. | 2025-09-11 |
| 00810113682761 | ManaMed Transducer Fixation Strap | Manamed, Inc. | 2025-09-11 |
| 00857599005257 | sam(R) Advanced Gel Capture Patch | ZETROZ SYSTEMS, LLC | 2024-10-10 |
| 00857599005172 | sam(R) Advanced Gel Capture Patch | ZETROZ SYSTEMS, LLC | 2024-10-10 |
| 00857599005165 | sam(R) Advanced Gel Capture Patch | ZETROZ SYSTEMS, LLC | 2024-10-10 |
| 07290103422011 | PainShield Patch | NANOVIBRONIX INC. | 2023-07-24 |
| 07290103421144 | PainShield 3.0 Actuator | NANOVIBRONIX INC. | 2023-07-16 |
| 00810113682396 | ManaSport+ | Manamed, Inc. | 2022-06-20 |
| 07290103421229 | Reusable Patch | NANOVIBRONIX INC. | 2019-07-28 |
| 07290103421250 | Reusable Facial Patch | NANOVIBRONIX INC. | 2019-07-28 |
| 08908008085307 | HILL Laboratories Company | SYRMA JOHARI MEDTECH LIMITED | 2019-01-11 |