Hope&Her Vaginal Dilators are indicated to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex. The set includes 6…
Hope&Her Vaginal Dilators are indicated to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex. The set includes 6 comfortable dilator sizes and an easy-to-attach universal handle. The dilators have a silky-smooth, seamless texture and are not made with BPA, Latex, or silicone. The patented, gentle-tapered design promotes an easy size transition from the smallest size up through the largest. The handle locks on easily and is very study to allow PT muscle manipulation.
Who Else Makes It
Registered in Guangdong.
Record
Regulatory record for Hope&Her Vaginal Dilators | Listed by | Lujena, Inc., United States |
| FDA product code | HDX |
| Device type | Dilator, Vaginal |
| Device class | Class 2 |
| Regulation | 21 CFR 884.3900 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2024-11-15 |
| Record revised | 2025-01-27 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.