Submission Details
| 510(k) Number | K063521 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 22, 2006 |
| Decision Date | February 05, 2007 |
| Days to Decision | 75 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
NISSIN PEDIATRIC SERIES WHEELCHAIR
Feb 2007
Decision
75d
Days
Class 1
Risk
About This 510(k) Submission
K063521 is an FDA 510(k) clearance for the NISSIN PEDIATRIC SERIES WHEELCHAIR, a Chair, With Casters (Class I — General Controls, product code INM), submitted by Nissin Medical, Inc. (Torrance, US). The FDA issued a Cleared decision on February 5, 2007, 75 days after receiving the submission on November 22, 2006. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3100.
Device Classification
| Product Code | INM — Chair, With Casters |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.3100 |
Manufacturer
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