The following data is part of a premarket notification filed by Design Specific Fletcher with the FDA for Compact Wheelchair Platform.
Device ID | K101723 |
510k Number | K101723 |
Device Name: | COMPACT WHEELCHAIR PLATFORM |
Classification | Chair, Positioning, Electric |
Applicant | DESIGN SPECIFIC FLETCHER UNIT 10 CABURN ENTERPRISE PARK THE BROYLE Ringmer East Sussex, GB Bn8 5np |
Contact | Richard Fletcher |
Correspondent | Richard Fletcher DESIGN SPECIFIC FLETCHER UNIT 10 CABURN ENTERPRISE PARK THE BROYLE Ringmer East Sussex, GB Bn8 5np |
Product Code | INO |
CFR Regulation Number | 890.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-06-18 |
Decision Date | 2010-12-23 |
Summary: | summary |