The following data is part of a premarket notification filed by Fast Wrap Co., Inc. with the FDA for Ortho Wrap.
| Device ID | K830622 |
| 510k Number | K830622 |
| Device Name: | ORTHO WRAP |
| Classification | Bandage, Elastic |
| Applicant | FAST WRAP CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FQM |
| CFR Regulation Number | 880.5075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-28 |
| Decision Date | 1983-06-20 |