The following data is part of a premarket notification filed by Fem-gard, Inc. with the FDA for Heel Gard.
| Device ID | K790954 |
| 510k Number | K790954 |
| Device Name: | HEEL GARD |
| Classification | Chair, Examination And Treatment |
| Applicant | FEM-GARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FRK |
| CFR Regulation Number | 880.6140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-22 |
| Decision Date | 1979-06-20 |