The following data is part of a premarket notification filed by Medical Compression Systems (dbn) Ltd. with the FDA for Activecare Dvt, Activecare+sft, And Activecare+dtx Systems.
| Device ID | K140755 |
| 510k Number | K140755 |
| Device Name: | ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEDICAL COMPRESSION SYSTEMS (DBN) LTD. 2 HA'ILAN ST. P.O. BOX 75 Or-akiva, IL 30600 |
| Contact | Adely Levy |
| Correspondent | Adely Levy MEDICAL COMPRESSION SYSTEMS (DBN) LTD. 2 HA'ILAN ST. P.O. BOX 75 Or-akiva, IL 30600 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-26 |
| Decision Date | 2014-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016525373 | K140755 | 000 |
| 00889024504653 | K140755 | 000 |
| 00889024504646 | K140755 | 000 |
| 00889024504622 | K140755 | 000 |
| 00889024504615 | K140755 | 000 |
| 00889024504530 | K140755 | 000 |