The following data is part of a premarket notification filed by Zetroz Inc with the FDA for Ztx Ultrasonic Diathermy Device.
| Device ID | K130978 |
| 510k Number | K130978 |
| Device Name: | ZTX ULTRASONIC DIATHERMY DEVICE |
| Classification | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat |
| Applicant | ZetrOZ INC 56 QUARRY ROAD Trumbull, CT 06611 |
| Contact | George K Lewis, Jr. |
| Correspondent | George K Lewis, Jr. ZetrOZ INC 56 QUARRY ROAD Trumbull, CT 06611 |
| Product Code | PFW |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-09 |
| Decision Date | 2013-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857599005097 | K130978 | 000 |
| 00857599005073 | K130978 | 000 |