The following data is part of a premarket notification filed by Koalaty Products, Inc. with the FDA for Models Ems 5.0, Ems 5.1.
| Device ID | K072795 |
| 510k Number | K072795 |
| Device Name: | MODELS EMS 5.0, EMS 5.1 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | KOALATY PRODUCTS, INC. 5015 N. CLARK AVE. Tampa, FL 33614 |
| Contact | Jeff Lenoir |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-10-01 |
| Decision Date | 2007-11-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80092237616648 | K072795 | 000 |