The following data is part of a premarket notification filed by Wfr/aquaplast Corp. with the FDA for Qfix Radiotherapy Chair.
| Device ID | K120916 |
| 510k Number | K120916 |
| Device Name: | QFIX RADIOTHERAPY CHAIR |
| Classification | Couch, Radiation Therapy, Powered |
| Applicant | WFR/AQUAPLAST CORP. 440 CHURCH ROAD Avondale, PA 19311 |
| Contact | Tim Wade |
| Correspondent | Tim Wade WFR/AQUAPLAST CORP. 440 CHURCH ROAD Avondale, PA 19311 |
| Product Code | JAI |
| CFR Regulation Number | 892.5770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-27 |
| Decision Date | 2012-06-20 |