← Product Code [KXQ](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/KXQ) · K010096

# MULTI CARE THERAPEUTIC VIBRATOR (K010096)

_Multicept A/S · KXQ · Mar 5, 2001 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/KXQ/K010096

## Device Facts

- **Applicant:** Multicept A/S
- **Product Code:** [KXQ](/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/KXQ.md)
- **Decision Date:** Mar 5, 2001
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 884.5960
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory Identification

A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic floor to increase muscle tone).

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/KXQ/K010096](https://fda.innolitics.com/submissions/OB/subpart-f%E2%80%94obstetrical-and-gynecological-therapeutic-devices/KXQ/K010096)

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