The following data is part of a premarket notification filed by Back-on-track, Inc. with the FDA for Back-on-trac, Model 101bot.
| Device ID | K984190 |
| 510k Number | K984190 |
| Device Name: | BACK-ON-TRAC, MODEL 101BOT |
| Classification | Apparatus, Traction, Non-powered |
| Applicant | BACK-ON-TRACK, INC. 344 CLARENDON St. Charles, MO 63301 |
| Contact | David A Sciortino |
| Correspondent | David A Sciortino BACK-ON-TRACK, INC. 344 CLARENDON St. Charles, MO 63301 |
| Product Code | HST |
| CFR Regulation Number | 888.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-23 |
| Decision Date | 1999-03-15 |