The following data is part of a premarket notification filed by Brotherston/pxi with the FDA for Pxi Pneumatic Compression Paddle.
| Device ID | K913436 |
| 510k Number | K913436 |
| Device Name: | PXI PNEUMATIC COMPRESSION PADDLE |
| Classification | System, X-ray, Photofluorographic |
| Applicant | BROTHERSTON/PXI 5708 WESTFIELD AVE. Pennsauken, NJ 08110 |
| Contact | James P Feeney |
| Correspondent | James P Feeney BROTHERSTON/PXI 5708 WESTFIELD AVE. Pennsauken, NJ 08110 |
| Product Code | IZG |
| CFR Regulation Number | 892.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-01 |
| Decision Date | 1992-11-05 |