K043239 is an FDA 510(k) clearance for the HEALTHSTAR ELITE. This device is classified as a Equipment, Traction, Powered (Class II - Special Controls, product code ITH).
Submitted by Hill Laboratories Co. (Frazer, US). The FDA issued a Cleared decision on December 22, 2004, 29 days after receiving the submission on November 23, 2004.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5900.
| 510(k) Number | K043239 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2004 |
| Decision Date | December 22, 2004 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ITH — Equipment, Traction, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5900 |