The following data is part of a premarket notification filed by Encompass Group, Llc. with the FDA for Patient Restraint.
| Device ID | K760618 |
| 510k Number | K760618 |
| Device Name: | PATIENT RESTRAINT |
| Classification | Restraint, Protective |
| Applicant | ENCOMPASS GROUP, LLC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMQ |
| CFR Regulation Number | 880.6760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-13 |
| Decision Date | 1976-11-24 |