The following data is part of a premarket notification filed by Rapid-aid Ltd./ltee with the FDA for Rapid-aid Therapeutic/scanning Ultrasound Gel.
| Device ID | K963169 |
| 510k Number | K963169 |
| Device Name: | RAPID-AID THERAPEUTIC/SCANNING ULTRASOUND GEL |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | RAPID-AID LTD./LTEE 4-3345 LAIRD ROAD Mississuaga,ontario, CA L5l 5r6 |
| Contact | George Schmidt |
| Correspondent | George Schmidt RAPID-AID LTD./LTEE 4-3345 LAIRD ROAD Mississuaga,ontario, CA L5l 5r6 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-14 |
| Decision Date | 1996-11-12 |