The following data is part of a premarket notification filed by Medical Compressions System (dbn) Ltd. with the FDA for Activecare+sft; Activecare+sft Homecare (activecare+sft-sub-category), Activecare+dtx ; Activecare+dtx Homecare (activecare+dtx-sub-category).
| Device ID | K142728 |
| 510k Number | K142728 |
| Device Name: | ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category) |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Medical Compressions System (DBN) Ltd. 12 Ha'Ilan Street, PO Box 75 Or Akiva, IL 30600 |
| Contact | Eyal Sandach |
| Correspondent | Adely Levy Medical Compressions System (DBN) Ltd. 12 Ha'Ilan Street, PO Box 75 Or Akiva, IL 30600 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-23 |
| Decision Date | 2014-12-04 |
| Summary: | summary |