The following data is part of a premarket notification filed by Wuhan Landing Medical Hi-tech Ltd with the FDA for Intermittent Pneumatic Compression Device.
| Device ID | K141390 |
| 510k Number | K141390 |
| Device Name: | INTERMITTENT PNEUMATIC COMPRESSION DEVICE |
| Classification | Sleeve, Limb, Compressible |
| Applicant | WUHAN LANDING MEDICAL HI-TECH LTD 818 GAOXIN RD EAST LAKE HIGH TECH DEVELOPMENT ZONE FLOORS 1&2,UNITS B&C&D BUILDING NO.B7 MED EQUIPMENT PK Wuham, CN 430206 |
| Contact | Yan Liu |
| Correspondent | Yan Liu WUHAN LANDING MEDICAL HI-TECH LTD 818 GAOXIN RD EAST LAKE HIGH TECH DEVELOPMENT ZONE FLOORS 1&2,UNITS B&C&D BUILDING NO.B7 MED EQUIPMENT PK Wuham, CN 430206 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2014-11-18 |
| Summary: | summary |