K920487 is an FDA 510(k) clearance for the MINI VIBRATOR. This device is classified as a Vibrator, Therapeutic (Class I - General Controls, product code IRO).
Submitted by Alimed, Inc. (Dedham, US). The FDA issued a Cleared decision on February 18, 1992, 19 days after receiving the submission on January 30, 1992.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5975.
| 510(k) Number | K920487 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 1992 |
| Decision Date | February 18, 1992 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IRO — Vibrator, Therapeutic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5975 |