The following data is part of a premarket notification filed by Permobil A.b. with the FDA for Trax, Powered Wheelchair, Model 308686-00-0.
Device ID | K993406 |
510k Number | K993406 |
Device Name: | TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0 |
Classification | Wheelchair, Powered |
Applicant | PERMOBIL A.B. ENGELBREKTS VAG 101 Sollentuna, SE S-191 62 |
Contact | Bengt Persson |
Correspondent | Bengt Persson PERMOBIL A.B. ENGELBREKTS VAG 101 Sollentuna, SE S-191 62 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-10-08 |
Decision Date | 2000-12-18 |
Summary: | summary |