510(k) K211513
- Device
- Sam X1 Long Duration Ultrasound Device
- Applicant
- ZetrOZ Systems, LLC
- 510(k) number
- K211513
- Product code
- PFW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-08-18
- Date received
- 2021-05-14
- Regulation
- 890.5300
- Classification name
- Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sabrina Lewis
- Address
- 56 Quarry Rd. Trumbull CT US 06611 06611
FDA Registration Numbers#
- 3006262007
- 3010765975
- 1648700
- 3009437400
- 2510425
- 3037609256
- 1528161
- 8040537
- 3011767724
- 3009155917
Source Documents#
Other 510(k) Records For Product Code PFW #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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