The following data is part of a premarket notification filed by Design Specific Ltd with the FDA for Standard Wheelchair Platform.
Device ID | K073565 |
510k Number | K073565 |
Device Name: | STANDARD WHEELCHAIR PLATFORM |
Classification | Chair, Positioning, Electric |
Applicant | DESIGN SPECIFIC LTD 1310 TEMPLAR BLVD. Norfolk, VA 23518 |
Contact | Dawn Edwards |
Correspondent | Dawn Edwards DESIGN SPECIFIC LTD 1310 TEMPLAR BLVD. Norfolk, VA 23518 |
Product Code | INO |
CFR Regulation Number | 890.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-12-19 |
Decision Date | 2009-02-06 |
Summary: | summary |