SAM 3.0 Multi-Hour Continuous Ultrasound Device
FDA 510(k) clearance K260076 · decided 2026-04-28
Clearance details
- K-number
- K260076
- Device name
- SAM 3.0 Multi-Hour Continuous Ultrasound Device
- Applicant
- ZetrOZ Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2026-01-12
- Decision date
- 2026-04-28
- Days to decision
- 106 days
- Clearance type
- Special
- Product code
- PFW
- Device class
- 2
- Regulation number
- 890.5300
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Trumbull, CT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| sam CS Long Duration Ultrasound Device (K233210) | ZetrOZ Systems, LLC | 2023-10-25 |
| sam 2.0 Long Ultrasound Device (K223019) | ZetrOZ Systems, LLC | 2023-06-23 |
| PainShield MD PLUS (K221210) | Nanovibronix, Inc. | 2022-11-23 |
| sam X1 Long Duration Ultrasound Device (K211513) | ZetrOZ Systems, LLC | 2021-08-18 |
| sam 2.0 Long Duration Ultrasound System (K191568) | ZetrOZ Systems, LLC | 2020-03-06 |
| ZTX ULTRASONIC DIATHERMY DEVICE (K130978) | Zetroz, Inc. | 2013-11-06 |
| PAINSHIELD MD (K081075) | Nano Vibronix , Ltd. | 2008-08-22 |
| HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL (K072256) | Hill Laboratories Co. | 2008-03-12 |
Recalls involving this device
No recalls on record reference this clearance.