The following data is part of a premarket notification filed by Devon Medical Products (jiangsu) Ltd. with the FDA for Devon 24r Deep Vein Thrombosis (dvt) Prevention Therapy System.
| Device ID | K173528 |
| 510k Number | K173528 |
| Device Name: | Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Devon Medical Products (Jiangsu) Ltd. East Half Of 1-2f, Appt D2 1, Qingfeng Road. Nantong, CN 226017 |
| Contact | Julian Chu |
| Correspondent | Julian Chu Devon Medical Products (Jiangsu) Ltd. East Half Of 1-2f, Appt D2 1, Qingfeng Road. Nantong, CN 226017 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-15 |
| Decision Date | 2018-02-06 |