The following data is part of a premarket notification filed by Breg, Inc. with the FDA for Kinesthetic Ability Trainer (k.a.t., Model 1000).
| Device ID | K911795 |
| 510k Number | K911795 |
| Device Name: | KINESTHETIC ABILITY TRAINER (K.A.T., MODEL 1000) |
| Classification | Apparatus, Vestibular Analysis |
| Applicant | BREG, INC. 344 22ND ST. Costa Mesa, CA 92627 |
| Contact | Nancy A Willcox |
| Correspondent | Nancy A Willcox BREG, INC. 344 22ND ST. Costa Mesa, CA 92627 |
| Product Code | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-22 |
| Decision Date | 1991-11-19 |