The following data is part of a premarket notification filed by Maxstar Industrial Co. Ltd. with the FDA for Compressible Limb Sleeve System.
| Device ID | K130385 |
| 510k Number | K130385 |
| Device Name: | COMPRESSIBLE LIMB SLEEVE SYSTEM |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | MAXSTAR INDUSTRIAL CO. LTD. 4568 W. 1ST STREET, STE 104 Los Angeles, CA 90004 |
| Contact | Daniel Nam |
| Correspondent | Daniel Nam MAXSTAR INDUSTRIAL CO. LTD. 4568 W. 1ST STREET, STE 104 Los Angeles, CA 90004 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-15 |
| Decision Date | 2014-02-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 38809040523691 | K130385 | 000 |