The following data is part of a premarket notification filed by Foryou Medical Electronics Co, Ltd with the FDA for Foryou Npwt Device.
| Device ID | K113236 |
| 510k Number | K113236 |
| Device Name: | FORYOU NPWT DEVICE |
| Classification | Negative Pressure Wound Therapy Powered Suction Pump |
| Applicant | FORYOU MEDICAL ELECTRONICS CO, LTD 3919 WILLIAM PENN HIGHWAY, SUITE 200 Murrysville, PA 15668 |
| Contact | Scott Wright |
| Correspondent | Scott Wright FORYOU MEDICAL ELECTRONICS CO, LTD 3919 WILLIAM PENN HIGHWAY, SUITE 200 Murrysville, PA 15668 |
| Product Code | OMP |
| CFR Regulation Number | 878.4780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-02 |
| Decision Date | 2013-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970076370014 | K113236 | 000 |