The following data is part of a premarket notification filed by Koalaty Products, Inc. with the FDA for Models Tens 7000, Ems 7500 And Twin Stim.
| Device ID | K080661 |
| 510k Number | K080661 |
| Device Name: | MODELS TENS 7000, EMS 7500 AND TWIN STIM |
| Classification | Stimulator, Muscle, Powered |
| Applicant | KOALATY PRODUCTS, INC. 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Contact | Jay Mansour |
| 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 | 2008-03-10 |
| Decision Date | 2008-03-24 |
| Summary: | summary |