The following data is part of a premarket notification filed by Nano Vibronix Ltd. with the FDA for Painshield Md.
| Device ID | K081075 |
| 510k Number | K081075 |
| Device Name: | PAINSHIELD MD |
| Classification | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Applicant | NANO VIBRONIX LTD. POB 6718 Efrat, IL 90435 |
| Contact | Eli Orbach |
| Correspondent | Eli Orbach NANO VIBRONIX LTD. POB 6718 Efrat, IL 90435 |
| Product Code | PFW |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-16 |
| Decision Date | 2008-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290103421236 | K081075 | 000 |
| 07290103421168 | K081075 | 000 |