The following data is part of a premarket notification filed by Physicians Digital Co. with the FDA for Kronamax Human Performance Lab.
| Device ID | K902219 |
| 510k Number | K902219 |
| Device Name: | KRONAMAX HUMAN PERFORMANCE LAB |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | PHYSICIANS DIGITAL CO. 12600 SAN PABLO AVE. SUITE A Richmond, CA 94805 |
| Contact | David R Schultz |
| Correspondent | David R Schultz PHYSICIANS DIGITAL CO. 12600 SAN PABLO AVE. SUITE A Richmond, CA 94805 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-16 |
| Decision Date | 1990-07-25 |