The following data is part of a premarket notification filed by Sportkat, Llc with the FDA for Korebalance (kinesthetic Ability Trainer).
| Device ID | K070676 |
| 510k Number | K070676 |
| Device Name: | KOREBALANCE (KINESTHETIC ABILITY TRAINER) |
| Classification | Apparatus, Vestibular Analysis |
| Applicant | SPORTKAT, LLC 1497 POINSETTIA AVE. STE. 157 Vista, CA 92083 |
| Contact | Damon R Lawson |
| Correspondent | Damon R Lawson SPORTKAT, LLC 1497 POINSETTIA AVE. STE. 157 Vista, CA 92083 |
| Product Code | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-12 |
| Decision Date | 2007-04-18 |
| Summary: | summary |