The following data is part of a premarket notification filed by Dane Technologies with the FDA for Dane Technologies Wheelchair Mover, Model Wm 2000.
Device ID | K073701 |
510k Number | K073701 |
Device Name: | DANE TECHNOLOGIES WHEELCHAIR MOVER, MODEL WM 2000 |
Classification | Wheelchair, Powered |
Applicant | DANE TECHNOLOGIES 7105 NORTHLAND TERRACE Brooklyn Park, MN 55428 |
Contact | Oliver Pittenger |
Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2007-12-31 |
Decision Date | 2008-01-28 |
Summary: | summary |