The following data is part of a premarket notification filed by Medical Compression System (dbn) Ltd. with the FDA for Activecare+sft;activecare+sft Homecare, Activecare+dtx;activecare+dtx Homecare.
| Device ID | K151377 |
| 510k Number | K151377 |
| Device Name: | ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEDICAL COMPRESSION SYSTEM (DBN) LTD. 12 HA'LLAN STREET, PO BOX 75 Or-akiva, IL 306000 |
| Contact | Eyal Sandach |
| Correspondent | Adely Levy MEDICAL COMPRESSION SYSTEMS (DBN) LTD. 12 HA'ILAN STREET, PO BOX 75 Or-akiva, IL 3060000 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-22 |
| Decision Date | 2015-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290016525513 | K151377 | 000 |
| 27290016525414 | K151377 | 000 |
| 27290016525421 | K151377 | 000 |
| 27290016525438 | K151377 | 000 |
| 27290016525445 | K151377 | 000 |
| 27290016525452 | K151377 | 000 |
| 27290016525469 | K151377 | 000 |
| 27290016525476 | K151377 | 000 |
| 27290016525483 | K151377 | 000 |
| 27290016525490 | K151377 | 000 |
| 27290016525506 | K151377 | 000 |
| 17290016525400 | K151377 | 000 |