The following data is part of a premarket notification filed by Primed Products, Inc. with the FDA for Test One.
| Device ID | K894662 |
| 510k Number | K894662 |
| Device Name: | TEST ONE |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | PRIMED PRODUCTS, INC. 808 PERSHING DR., SUITE 104 Silver Spring, MD 20910 |
| Contact | Linda Gorvett |
| Correspondent | Linda Gorvett PRIMED PRODUCTS, INC. 808 PERSHING DR., SUITE 104 Silver Spring, MD 20910 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-12-13 |