Panels › Physical Medicine › Product code IKK · Class 2
System, Isokinetic Testing And Evaluation
Regulation 890.1925
0510(k)s in 12 months (61 all time)
0recalls in 12 months (4 all time)
1recalls that name a 510(k)
Top companies in IKK
| Company | 510(k)s | Recalls |
|---|---|---|
| Biodex Corp. | 7 | 0 |
| Cybex | 7 | 0 |
| Loredan Biomedical, Inc. | 7 | 0 |
| Kent Design & Manufacturing, Inc. | 6 | 0 |
| Biodan Medical Systems, Ltd. | 3 | 0 |
| Isotechnologies, Inc. | 3 | 0 |
| Medx Corp. | 3 | 0 |
| Orthopedic Systems, Inc. | 2 | 0 |
| Ames Technology, Inc. | 1 | 0 |
| Baltimore Therapeutic Equipment Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 1986 | K861986 | LIDO BACK Loredan Biomedical, Inc. | IKK |
| May 27, 1986 | K861632 | SIMS CHAIR Twin City Surgical, Inc. | IKK |
| May 27, 1986 | K861622 | SAGITTAL & ROTARY ACT/PASS KNEE LIGAMENT TESTER Orthopedic Systems, Inc. | IKK |
| Apr 18, 1986 | K861206 | NAUTILUS LEG EXTENSION TESTING & REHABILITATION Nautilus Sports/Medical Industries, Inc. | IKK |
| Apr 18, 1986 | K860821 | BIODEX SYSTEM Biodex Corp. | IKK |
| Feb 19, 1985 | K844368 | LINEAR LIFT DEVICE Cybex | IKK |
| Nov 29, 1984 | K843739 | CYBEX TORSO TESTING & REHABILITATION Cybex | IKK |
| Nov 23, 1984 | K844060 | ISOSTATION ANKLE/SUBTALAR MACHINE A-100 Isotechnologies, Inc. | IKK |
| Jun 22, 1984 | K842296 | ISOSTATION LOWER BACK MACHINE Isotechnologies, Inc. | IKK |
| May 14, 1984 | K841849 | ISOSTATION SHOULDER MACHINE Isotechnologies, Inc. | IKK |
| Sep 26, 1983 | K832770 | LANE ONE Loredan Biomedical, Inc. | IKK |
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