The following data is part of a premarket notification filed by Isotechnologies, Inc. with the FDA for Isostation Ankle/subtalar Machine A-100.
| Device ID | K844060 |
| 510k Number | K844060 |
| Device Name: | ISOSTATION ANKLE/SUBTALAR MACHINE A-100 |
| Classification | System, Isokinetic Testing And Evaluation |
| Applicant | ISOTECHNOLOGIES, INC. P.O. BOX 1239 Hillsborough, NC 27278 |
| Contact | Martin |
| Correspondent | Martin ISOTECHNOLOGIES, INC. P.O. BOX 1239 Hillsborough, NC 27278 |
| Product Code | IKK |
| CFR Regulation Number | 890.1925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-18 |
| Decision Date | 1984-11-23 |