The following data is part of a premarket notification filed by National Therapy Products Inc. with the FDA for Wavelength Multi-purpose Ultrasound Gel.
| Device ID | K012522 |
| 510k Number | K012522 |
| Device Name: | WAVELENGTH MULTI-PURPOSE ULTRASOUND GEL |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2001-10-18 |