Panels › Physical Medicine › Product code IQE · Class 1
Orthosis, Lumbar
Regulation 890.3490
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in IQE
| Company | 510(k)s | Recalls |
|---|---|---|
| Bandwagon, Inc. | 1 | 0 |
| Fred Sammons, Inc. | 1 | 0 |
| Obus Forme, Ltd. | 1 | 0 |
| Surgical Appliance Industries, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 1982 | K821682 | TRUNCAL ORTHOSIS Surgical Appliance Industries, Inc. | IQE |
| Jan 29, 1982 | K820051 | OBUS FORME ORTHOPEDIC BRACE, UPRIGHT Obus Forme, Ltd. | IQE |
| Oct 6, 1981 | K812719 | PROSANA BELT Bandwagon, Inc. | IQE |
| Mar 4, 1981 | K810450 | TRUNCAL ORTHOSIS Fred Sammons, Inc. | IQE |
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