The following data is part of a premarket notification filed by Optima Health Solutions International, Inc. with the FDA for Khan Kinetic Treatment Device (kkt-m1).
| Device ID | K060043 |
| 510k Number | K060043 |
| Device Name: | KHAN KINETIC TREATMENT DEVICE (KKT-M1) |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | OPTIMA HEALTH SOLUTIONS INTERNATIONAL, INC. UNIT 303, 828 WEST 8TH AVE. Vancouver, British Columbia, CA V5z 1e2 |
| Contact | Bram Ramjiawan |
| Correspondent | Bram Ramjiawan OPTIMA HEALTH SOLUTIONS INTERNATIONAL, INC. UNIT 303, 828 WEST 8TH AVE. Vancouver, British Columbia, CA V5z 1e2 |
| Product Code | LXM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-06 |
| Decision Date | 2006-03-23 |
| Summary: | summary |