The following data is part of a premarket notification filed by Richway Intl., Inc. with the FDA for Bio-mat 2000.
| Device ID | K072534 |
| 510k Number | K072534 |
| Device Name: | BIO-MAT 2000 |
| Classification | Pad, Heating, Powered |
| Applicant | RICHWAY INTL., INC. 1314 SOUTH KING ST., SUITE 520 Honolulu, HI 96814 |
| Contact | Leroy Klima |
| Correspondent | Leroy Klima RICHWAY INTL., INC. 1314 SOUTH KING ST., SUITE 520 Honolulu, HI 96814 |
| Product Code | IRT |
| CFR Regulation Number | 890.5740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-07 |
| Decision Date | 2008-02-08 |
| Summary: | summary |