The following data is part of a premarket notification filed by Fena Design, Inc. with the FDA for Vertran Standing Wheelchair.
Device ID | K011530 |
510k Number | K011530 |
Device Name: | VERTRAN STANDING WHEELCHAIR |
Classification | Wheelchair, Standup |
Applicant | FENA DESIGN, INC. PO BOX 560 Stillwater, MN 55082 |
Contact | Elaine Duncan |
Correspondent | Elaine Duncan FENA DESIGN, INC. PO BOX 560 Stillwater, MN 55082 |
Product Code | IPL |
CFR Regulation Number | 890.3900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-17 |
Decision Date | 2001-10-16 |