The following data is part of a premarket notification filed by Transmotion Medical Inc. with the FDA for Power Drive Chair, Model: Tmm6.
Device ID | K091043 |
510k Number | K091043 |
Device Name: | POWER DRIVE CHAIR, MODEL: TMM6 |
Classification | Stretcher, Wheeled, Powered |
Applicant | TRANSMOTION MEDICAL INC. 5905 FAWN LN. Cleveland, OH 44124 |
Contact | Edward A Kroll |
Correspondent | Edward A Kroll TRANSMOTION MEDICAL INC. 5905 FAWN LN. Cleveland, OH 44124 |
Product Code | INK |
CFR Regulation Number | 890.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-04-13 |
Decision Date | 2009-05-11 |
Summary: | summary |