K862888 is an FDA 510(k) clearance for the PERAMBULATOR (STROLLER). This device is classified as a Stroller, Adaptive (Class I - General Controls, product code LBE).
Submitted by Mednet, Inc. (Battle Creek, US). The FDA issued a Cleared decision on August 13, 1986, 22 days after receiving the submission on July 22, 1986.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.3850.
| 510(k) Number | K862888 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 1986 |
| Decision Date | August 13, 1986 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | LBE — Stroller, Adaptive |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.3850 |