K860837 is an FDA 510(k) clearance for the HOYER ONE-TOUCH POWER LIFTER. This device is classified as a Lift, Patient, Non-ac-powered (Class I - General Controls, product code FSA).
Submitted by Ted Hoyer & Co., Inc. (Oshkosh, US). The FDA issued a Cleared decision on March 27, 1986, 22 days after receiving the submission on March 5, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5510.
| 510(k) Number | K860837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 1986 |
| Decision Date | March 27, 1986 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FSA — Lift, Patient, Non-ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5510 |