The following data is part of a premarket notification filed by Economic Holland B.v. with the FDA for Aerolet Toilet Lift, Model Aer-01.
| Device ID | K031045 |
| 510k Number | K031045 |
| Device Name: | AEROLET TOILET LIFT, MODEL AER-01 |
| Classification | Chair, Positioning, Electric |
| Applicant | ECONOMIC HOLLAND B.V. 6785 FOREST OAK DR. Clemmons, NC 27012 |
| Contact | Stephanie Wolfkamp |
| Correspondent | Stephanie Wolfkamp ECONOMIC HOLLAND B.V. 6785 FOREST OAK DR. Clemmons, NC 27012 |
| Product Code | INO |
| CFR Regulation Number | 890.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-30 |
| Decision Date | 2003-07-10 |
| Summary: | summary |