K984190 is an FDA 510(k) clearance for the BACK-ON-TRAC, MODEL 101BOT. This device is classified as a Apparatus, Traction, Non-powered (Class I - General Controls, product code HST).
Submitted by Back-On-Track, Inc. (St. Charles, US). The FDA issued a Cleared decision on March 15, 1999, 112 days after receiving the submission on November 23, 1998.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 888.5850.
| 510(k) Number | K984190 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 1998 |
| Decision Date | March 15, 1999 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HST — Apparatus, Traction, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 888.5850 |