The following data is part of a premarket notification filed by Devon Medical Products (jiangsu) Ltd with the FDA for Devon 62 Deep Vein Thrombosis (dvt) Prevention Therapy Device.
| Device ID | K182578 |
| 510k Number | K182578 |
| Device Name: | Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Devon Medical Products (Jiangsu) Ltd East Half Of 1-2F, Appt D2, Qingfeng Road Nantong, CN 226017 |
| Contact | Neil Cheng |
| Correspondent | Ruth Wu Devon MD LLC 700 American Ave Ste 100 King Of Prussia, PA 19406 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-19 |
| Decision Date | 2019-02-21 |
| Summary: | summary |