The following data is part of a premarket notification filed by Usa Laser Therapeutics, Inc. with the FDA for Bodihealth System.
| Device ID | K052836 |
| 510k Number | K052836 |
| Device Name: | BODIHEALTH SYSTEM |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | USA LASER THERAPEUTICS, INC. 12101 CULLEN BLVD., #A Houston, TX 77047 |
| Contact | M. Joyce Heinrich |
| Correspondent | M. Joyce Heinrich USA LASER THERAPEUTICS, INC. 12101 CULLEN BLVD., #A Houston, TX 77047 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-06 |
| Decision Date | 2007-02-13 |