The following data is part of a premarket notification filed by National Therapy Products Inc. with the FDA for Wavelenght Ultrasound Lotion.
| Device ID | K013212 |
| 510k Number | K013212 |
| Device Name: | WAVELENGHT ULTRASOUND LOTION |
| Classification | Media, Coupling, Ultrasound |
| Applicant | NATIONAL THERAPY PRODUCTS INC. 2-191 ROWNTREE DAIRY RD. Woodbridge, Ontario, CA Lhl 8b8 |
| Contact | Paul L Hooey |
| Correspondent | Paul L Hooey NATIONAL THERAPY PRODUCTS INC. 2-191 ROWNTREE DAIRY RD. Woodbridge, Ontario, CA Lhl 8b8 |
| Product Code | MUI |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-25 |
| Decision Date | 2002-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628108100165 | K013212 | 000 |
| 00628108100127 | K013212 | 000 |
| 00628108100066 | K013212 | 000 |
| 00812433025204 | K013212 | 000 |
| 00816864020326 | K013212 | 000 |
| 00815290013872 | K013212 | 000 |
| 10628108100308 | K013212 | 000 |
| 10816864020323 | K013212 | 000 |
| 10660584000925 | K013212 | 000 |