The following data is part of a premarket notification filed by Medical Compression Systems (dbn) Ltd. with the FDA for Activecare Home.
| Device ID | K160431 |
| 510k Number | K160431 |
| Device Name: | ActiveCare Home |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEDICAL COMPRESSION SYSTEMS (DBN) LTD. 12 HA'ILAN STREET, PO BOX 75 Or Akiva, IL 30600 |
| Contact | Yaki Barak |
| Correspondent | Orly Maor ORLY MAOR 25 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 | 2016-02-16 |
| Decision Date | 2016-07-13 |
| Summary: | summary |