PainShield MD PLUS
Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat
NanoVibronix, Inc.
The following data is part of a premarket notification filed by Nanovibronix, Inc. with the FDA for Painshield Md Plus.
Pre-market Notification Details
| Device ID | K221210 |
| 510k Number | K221210 |
| Device Name: | PainShield MD PLUS |
| Classification | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Applicant | NanoVibronix, Inc. 525 Executive Blvd. Elmsford, NY 10523 |
| Contact | Hrishikesh Gadagkar |
| Correspondent | Hrishikesh Gadagkar NanoVibronix, Inc. 525 Executive Blvd. Elmsford, NY 10523 |
| Product Code | PFW |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-27 |
| Decision Date | 2022-11-23 |
Trademark Results [PainShield MD PLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PAINSHIELD MD PLUS 98316388 not registered Live/Pending |
NanoVibronix, Inc. 2023-12-15 |
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