Submission Details
| 510(k) Number | K895382 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 30, 1989 |
| Decision Date | October 16, 1989 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
Cleared
Traditional
VIBRA-TRAC TRACTION TABLE
Oct 1989
Decision
47d
Days
Class 1
Risk
About This 510(k) Submission
K895382 is an FDA 510(k) clearance for the VIBRA-TRAC TRACTION TABLE, a Accessories, Traction (Class I — General Controls, product code ILZ), submitted by Vibra-Trac Industries (Twin Falls, US). The FDA issued a Cleared decision on October 16, 1989, 47 days after receiving the submission on August 30, 1989. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5925.
Device Classification
| Product Code | ILZ — Accessories, Traction |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5925 |
Manufacturer
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