Submission Details
| 510(k) Number | K851256 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 28, 1985 |
| Decision Date | June 28, 1985 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
Cleared
Traditional
MOBIE SCOOTER
Jun 1985
Decision
92d
Days
Class 2
Risk
About This 510(k) Submission
K851256 is an FDA 510(k) clearance for the MOBIE SCOOTER, a Vehicle, Motorized 3-wheeled (Class II — Special Controls, product code INI), submitted by Everest & Jennings, Inc. (Camarillo, US). The FDA issued a Cleared decision on June 28, 1985, 92 days after receiving the submission on March 28, 1985. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3800.
Device Classification
| Product Code | INI — Vehicle, Motorized 3-wheeled |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.3800 |
Manufacturer
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