The following data is part of a premarket notification filed by Setma, Inc. with the FDA for Variable Height Transfer Chair.
Device ID | K841398 |
510k Number | K841398 |
Device Name: | VARIABLE HEIGHT TRANSFER CHAIR |
Classification | Lift, Patient, Non-ac-powered |
Applicant | SETMA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FSA |
CFR Regulation Number | 880.5510 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-03 |
Decision Date | 1984-05-07 |