The following data is part of a premarket notification filed by Inarex Corporation with the FDA for Thermal Massage Bed, Model 2d-gx.
| Device ID | K102281 |
| 510k Number | K102281 |
| Device Name: | THERMAL MASSAGE BED, MODEL 2D-GX |
| Classification | Table, Physical Therapy, Multi Function |
| Applicant | INAREX CORPORATION MIGUN TECHNO WORLD 2 C-DONG 2 C-DONG 524, YONGSAN-DONG Yuseong-gu, Daejon, KR 533-1 |
| Contact | Eileen Yang |
| Correspondent | Eileen Yang INAREX CORPORATION MIGUN TECHNO WORLD 2 C-DONG 2 C-DONG 524, YONGSAN-DONG Yuseong-gu, Daejon, KR 533-1 |
| Product Code | JFB |
| CFR Regulation Number | 890.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-11 |
| Decision Date | 2010-12-22 |
| Summary: | summary |