K790587 is an FDA 510(k) clearance for the CANVAS WEDGE. This device is classified as a Components, Exercise (Class I - General Controls, product code IOD).
Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 3, 1979, 7 days after receiving the submission on March 27, 1979.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5350.
| 510(k) Number | K790587 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 1979 |
| Decision Date | April 03, 1979 |
| Days to Decision | 7 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IOD — Components, Exercise |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5350 |