The following data is part of a premarket notification filed by Bandwagon, Inc. with the FDA for Prosana Belt.
| Device ID | K812719 |
| 510k Number | K812719 |
| Device Name: | PROSANA BELT |
| Classification | Orthosis, Lumbar |
| Applicant | BANDWAGON, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IQE |
| CFR Regulation Number | 890.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-25 |
| Decision Date | 1981-10-06 |