The following data is part of a premarket notification filed by United Chair Mfg., Llc. with the FDA for United #1018-freedom Series, United #2018-comfort Series, United #3018-elegance Series, United #5018-master Series.
Device ID | K002318 |
510k Number | K002318 |
Device Name: | UNITED #1018-FREEDOM SERIES, UNITED #2018-COMFORT SERIES, UNITED #3018-ELEGANCE SERIES, UNITED #5018-MASTER SERIES |
Classification | Chair, Positioning, Electric |
Applicant | UNITED CHAIR MFG., LLC. 2097 S. HAMILTON RD. SUITE 101 Columbus, OH 43232 |
Contact | Douglas A Hanby |
Correspondent | Douglas A Hanby UNITED CHAIR MFG., LLC. 2097 S. HAMILTON RD. SUITE 101 Columbus, OH 43232 |
Product Code | INO |
CFR Regulation Number | 890.3110 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-07-31 |
Decision Date | 2000-10-11 |