The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Multi-purpose Utility Restraint/body Holder.
| Device ID | K963480 |
| 510k Number | K963480 |
| Device Name: | MULTI-PURPOSE UTILITY RESTRAINT/BODY HOLDER |
| Classification | Restraint, Wheelchair, Non-protective |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Camille Matlock |
| Correspondent | Camille Matlock DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | KID |
| CFR Regulation Number | 890.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1997-01-22 |
| Summary: | summary |