The following data is part of a premarket notification filed by Iyia Technologies, Inc. with the FDA for Whs-1000 Wound Healing System.
| Device ID | K050156 |
| 510k Number | K050156 |
| Device Name: | WHS-1000 WOUND HEALING SYSTEM |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | IYIA TECHNOLOGIES, INC. 11440 WEST BERNARDO COURT SUITE 380 San Diego, CA 92127 |
| Contact | Alan Donald |
| Correspondent | Alan Donald IYIA TECHNOLOGIES, INC. 11440 WEST BERNARDO COURT SUITE 380 San Diego, CA 92127 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-24 |
| Decision Date | 2005-06-17 |
| Summary: | summary |