The following data is part of a premarket notification filed by Penox Technologies, Inc. with the FDA for Penox Performer Wheelchair.
| Device ID | K852109 |
| 510k Number | K852109 |
| Device Name: | PENOX PERFORMER WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | PENOX TECHNOLOGIES, INC. ONE PENOX PLAZA, COMMERCE RD. P.O. BOX 785 Pittston, PA 18640 |
| Contact | Thana A Savo |
| Correspondent | Thana A Savo PENOX TECHNOLOGIES, INC. ONE PENOX PLAZA, COMMERCE RD. P.O. BOX 785 Pittston, PA 18640 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-15 |
| Decision Date | 1985-08-22 |