The following data is part of a premarket notification filed by Pneumex, Inc. with the FDA for Vibro-trac.
| Device ID | K092731 |
| 510k Number | K092731 |
| Device Name: | VIBRO-TRAC |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | PNEUMEX, INC. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Contact | Jean Asquith |
| Correspondent | Jean Asquith PNEUMEX, INC. 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746 |
| Product Code | JFB |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-04 |
| Decision Date | 2010-06-10 |
| Summary: | summary |