The following data is part of a premarket notification filed by Orbitec Technologies Corp. with the FDA for Ped Alert.
| Device ID | K950656 |
| 510k Number | K950656 |
| Device Name: | PED ALERT |
| Classification | Device, Warning, Overload, External Limb, Powered |
| Applicant | ORBITEC TECHNOLOGIES CORP. 402 GAMMON PLACE SUITE 200 Madison, WI 53719 |
| Contact | Thomas M Crabb |
| Correspondent | Thomas M Crabb ORBITEC TECHNOLOGIES CORP. 402 GAMMON PLACE SUITE 200 Madison, WI 53719 |
| Product Code | IRN |
| CFR Regulation Number | 890.5575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-13 |
| Decision Date | 1995-10-25 |