The following data is part of a premarket notification filed by York Biomedical Inc with the FDA for Back-tek.
| Device ID | K101227 |
| 510k Number | K101227 |
| Device Name: | BACK-TEK |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | YORK BIOMEDICAL INC 13417 QUIVAS ST Westminster, CO 80234 |
| Contact | Calley Herzog |
| Correspondent | Calley Herzog YORK BIOMEDICAL INC 13417 QUIVAS ST Westminster, CO 80234 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-03 |
| Decision Date | 2010-06-23 |
| Summary: | summary |