The following data is part of a premarket notification filed by Boulder Impact Monitors, Inc. with the FDA for Force Guard I.
| Device ID | K882974 |
| 510k Number | K882974 |
| Device Name: | FORCE GUARD I |
| Classification | Device, Warning, Overload, External Limb, Powered |
| Applicant | BOULDER IMPACT MONITORS, INC. 2525 ARAPAHOE SUITE E4 Boulder, CO 80302 |
| Contact | James D Little |
| Correspondent | James D Little BOULDER IMPACT MONITORS, INC. 2525 ARAPAHOE SUITE E4 Boulder, CO 80302 |
| Product Code | IRN |
| CFR Regulation Number | 890.5575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-15 |
| Decision Date | 1988-11-04 |