The following data is part of a premarket notification filed by Medical Industries America, Inc. with the FDA for C' Airecush Seat Cushion.
| Device ID | K864109 |
| 510k Number | K864109 |
| Device Name: | C' AIRECUSH SEAT CUSHION |
| Classification | Cushion, Flotation |
| Applicant | MEDICAL INDUSTRIES AMERICA, INC. 6A NELSON ST. ANNANDALE N.S.W. Australia 2038, AU |
| Contact | Russell F Bird |
| Correspondent | Russell F Bird MEDICAL INDUSTRIES AMERICA, INC. 6A NELSON ST. ANNANDALE N.S.W. Australia 2038, AU |
| Product Code | KIC |
| CFR Regulation Number | 890.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-21 |
| Decision Date | 1986-11-14 |