The following data is part of a premarket notification filed by Lumex, Inc. with the FDA for 577es (ergosense).
| Device ID | K945257 |
| 510k Number | K945257 |
| Device Name: | 577ES (ERGOSENSE) |
| Classification | Chair, Positioning, Electric |
| Applicant | LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
| Contact | Joseph Mueller |
| Correspondent | Joseph Mueller LUMEX, INC. 100 SPENCE ST. Bay Shore, NY 11706 -2290 |
| Product Code | INO |
| CFR Regulation Number | 890.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-28 |
| Decision Date | 1995-04-26 |