The following data is part of a premarket notification filed by Optima Health Solutions International Corporation with the FDA for Khan Kinetic Treatment (kkt-m2).
| Device ID | K130666 |
| 510k Number | K130666 |
| Device Name: | KHAN KINETIC TREATMENT (KKT-M2) |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION 303 - 828 W 8th Avenue Vancouver, CA V5z 1e2 |
| Contact | Farhad Ghani |
| Correspondent | Farhad Ghani OPTIMA HEALTH SOLUTIONS INTERNATIONAL CORPORATION 303 - 828 W 8th Avenue Vancouver, 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 | 2013-03-12 |
| Decision Date | 2014-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B854M20 | K130666 | 000 |