The following data is part of a premarket notification filed by Medical Compression Systems (dbn) Ltd. with the FDA for Activecare Sft.
| Device ID | K110159 |
| 510k Number | K110159 |
| Device Name: | ACTIVECARE SFT |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEDICAL COMPRESSION SYSTEMS (DBN) LTD. 25 A SIRKIN STREET Kfar Saba, IL 44421 |
| Contact | Orly Maor |
| Correspondent | Orly Maor MEDICAL COMPRESSION SYSTEMS (DBN) LTD. 25 A SIRKIN STREET Kfar Saba, IL 44421 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-19 |
| Decision Date | 2011-05-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ACTIVECARE SFT 76668524 3639986 Live/Registered |
ZIMMER SURGICAL, INC. 2006-11-06 |