K942508 is an FDA 510(k) clearance for the ROBO. This device is classified as a Vehicle, Motorized 3-wheeled (Class II - Special Controls, product code INI).
Submitted by Permobil AB (Timra, SE). The FDA issued a Cleared decision on November 7, 1994, 165 days after receiving the submission on May 26, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3800.
| 510(k) Number | K942508 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | May 26, 1994 |
| Decision Date | November 07, 1994 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | - |
| Product Code | INI - Vehicle, Motorized 3-wheeled |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.3800 |