The following data is part of a premarket notification filed by Amysystems with the FDA for Amyseat Tilt/recline Seating.
Device ID | K011006 |
510k Number | K011006 |
Device Name: | AMYSEAT TILT/RECLINE SEATING |
Classification | Wheelchair, Powered |
Applicant | AMYSYSTEMS 178, WEST SERVICE RD. Champlain, NY 12919 |
Contact | Sylvain Dugas |
Correspondent | Sylvain Dugas AMYSYSTEMS 178, WEST SERVICE RD. Champlain, NY 12919 |
Product Code | ITI |
CFR Regulation Number | 890.3860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-04-04 |
Decision Date | 2001-05-11 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00827482201769 | K011006 | 000 |