The following data is part of a premarket notification filed by Charles D. Bell, Inc. with the FDA for The Ergosystem Chair.
Device ID | K863728 |
510k Number | K863728 |
Device Name: | THE ERGOSYSTEM CHAIR |
Classification | Chair, Ophthalmic, Ac-powered |
Applicant | CHARLES D. BELL, INC. 1214 RTE 130 Westville, NJ 08093 |
Contact | Bell, Jr |
Correspondent | Bell, Jr CHARLES D. BELL, INC. 1214 RTE 130 Westville, NJ 08093 |
Product Code | HME |
CFR Regulation Number | 886.1140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-23 |
Decision Date | 1986-10-31 |