The following data is part of a premarket notification filed by Evermed Corp. with the FDA for Galaxy Series Wheelchair.
| Device ID | K023993 |
| 510k Number | K023993 |
| Device Name: | GALAXY SERIES WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | EVERMED CORP. 4999 E. LA PALMA AVE. Anaheim, CA 92807 |
| Contact | Calvin Chang |
| Correspondent | Calvin Chang EVERMED CORP. 4999 E. LA PALMA AVE. Anaheim, CA 92807 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-03 |
| Decision Date | 2002-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784028019 | K023993 | 000 |
| 00840117322684 | K023993 | 000 |