The following data is part of a premarket notification filed by Bio Compression Systems, Inc. with the FDA for Sequential Circulators Sc-1004-dl, Sc-1008-dl, Sc-2004-dl, Sc-2008-dl, Sc-4004-dl, Sc-4008-dl.
| Device ID | K213533 |
| 510k Number | K213533 |
| Device Name: | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | Bio Compression Systems, Inc. 120 West Commercial Ave Moonachie, NJ 07074 |
| Contact | Marc Somelofski |
| Correspondent | Marc Somelofski Bio Compression Systems, Inc. 120 West Commercial Ave Moonachie, NJ 07074 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-05 |
| Decision Date | 2022-02-16 |