The following data is part of a premarket notification filed by Daesung Maref Co., Ltd. with the FDA for Air Compressible Limb Therapy System.
| Device ID | K150033 |
| 510k Number | K150033 |
| Device Name: | Air Compressible Limb Therapy System |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | DAESUNG MAREF CO., LTD. 298-24, GONGDAN-RO Gunpo-shi, KR 435-862 |
| Contact | Jae-wha Lee |
| Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-09 |
| Decision Date | 2015-04-20 |
| Summary: | summary |