The following data is part of a premarket notification filed by Isotechnologies, Inc. with the FDA for Isotechnologies Back Tracker And Back Works Softwa.
| Device ID | K933063 |
| 510k Number | K933063 |
| Device Name: | ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA |
| Classification | Goniometer, Ac-powered |
| Applicant | ISOTECHNOLOGIES, INC. P.O. BOX 1239 Hillsborough, NC 27278 |
| Contact | George Fleming |
| Correspondent | George Fleming ISOTECHNOLOGIES, INC. P.O. BOX 1239 Hillsborough, NC 27278 |
| Product Code | KQX |
| CFR Regulation Number | 888.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-22 |
| Decision Date | 1994-01-27 |