K221210 is an FDA 510(k) clearance for the PainShield MD PLUS. This device is classified as a Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code PFW).
Submitted by Nanovibronix, Inc. (Elmsford, US). The FDA issued a Cleared decision on November 23, 2022, 210 days after receiving the submission on April 27, 2022.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5300. Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation..
| 510(k) Number | K221210 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 27, 2022 |
| Decision Date | November 23, 2022 |
| Days to Decision | 210 days |
| Submission Type | Special |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | PFW - Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5300 |
| Definition | Ultrasonic Diathermy Devices Which Include Stationary Applicators Enabling Hands-free Operation. |