The following data is part of a premarket notification filed by Medical Compression Systems (dbn) Ltd. with the FDA for Activecare ++ System.
| Device ID | K060146 |
| 510k Number | K060146 |
| Device Name: | ACTIVECARE ++ SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | MEDICAL COMPRESSION SYSTEMS (DBN) LTD. 7 JABOTINSKY STREET MOSHE AVIV TOWER Ramat Gan, IL 52520 |
| Contact | Dorit Winitz |
| Correspondent | Dorit Winitz MEDICAL COMPRESSION SYSTEMS (DBN) LTD. 7 JABOTINSKY STREET MOSHE AVIV TOWER Ramat Gan, IL 52520 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-19 |
| Decision Date | 2006-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016525397 | K060146 | 000 |
| 07290016525380 | K060146 | 000 |