K940238 is an FDA 510(k) clearance for the TUMBLE FORMS JUNIOR TRISTANDER. This device is classified as a Table, Mechanical (Class I - General Controls, product code INW).
Submitted by Camp Intl., Inc. (Jackson, US). The FDA issued a Cleared decision on March 7, 1994, 47 days after receiving the submission on January 19, 1994.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3750.
| 510(k) Number | K940238 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1994 |
| Decision Date | March 07, 1994 |
| Days to Decision | 47 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | INW — Table, Mechanical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3750 |