Submission Details
| 510(k) Number | K123834 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 13, 2012 |
| Decision Date | August 13, 2013 |
| Days to Decision | 243 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
EASYSTAND BANTAM MEDIUM
Aug 2013
Decision
243d
Days
Class 2
Risk
About This 510(k) Submission
K123834 is an FDA 510(k) clearance for the EASYSTAND BANTAM MEDIUM, a Chair, Positioning, Electric (Class II — Special Controls, product code INO), submitted by Altimate Medical, Inc. (Morton, US). The FDA issued a Cleared decision on August 13, 2013, 243 days after receiving the submission on December 13, 2012. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3110.
Device Classification
| Product Code | INO — Chair, Positioning, Electric |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 890.3110 |
Manufacturer
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