The following data is part of a premarket notification filed by Impact Monitors, Inc. with the FDA for Forceguard.
| Device ID | K955034 |
| 510k Number | K955034 |
| Device Name: | FORCEGUARD |
| Classification | Device, Warning, Overload, External Limb, Powered |
| Applicant | IMPACT MONITORS, INC. 1430 FLORIDA AVE,STE 218 Longmont, CO 80501 |
| Contact | Susan Julio |
| Correspondent | Susan Julio IMPACT MONITORS, INC. 1430 FLORIDA AVE,STE 218 Longmont, CO 80501 |
| Product Code | IRN |
| CFR Regulation Number | 890.5575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-02 |
| Decision Date | 1996-04-10 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FORCEGUARD 85547419 4343541 Live/Registered |
Red Wing Shoe Company, Inc. 2012-02-20 |
![]() FORCEGUARD 85027800 4165060 Dead/Cancelled |
Leading Edge Innovations, Inc. 2010-04-30 |
![]() FORCEGUARD 77698534 not registered Dead/Abandoned |
Principal Coatings 2009-03-25 |
![]() FORCEGUARD 74485584 1926335 Dead/Cancelled |
GMI Holdings, Inc. 1994-02-02 |