The following data is part of a premarket notification filed by Maddak, Inc. with the FDA for Split Seat Positioning Chair.
Device ID | K841691 |
510k Number | K841691 |
Device Name: | SPLIT SEAT POSITIONING CHAIR |
Classification | Chair, Adjustable, Mechanical |
Applicant | MADDAK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | INN |
CFR Regulation Number | 890.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-23 |
Decision Date | 1984-05-09 |