Wave
The WAVE consists of an encapsulated vibration motor, connected by a length of wire, to a battery/power switch module. The vibration motor end is inserted into the vagina. The vibratory…
The WAVE consists of an encapsulated vibration motor, connected by a length of wire, to a battery/power switch module. The vibration motor end is inserted into the vagina. The vibratory stimulus is delivered through the end of the device which is composed of a stainless-steel shroud and a soft jacket. This jacket extends continuously down the length of the shaft, forming a closed system covering all features, ending at the battery/power switch module. The vibration motor generates a nominal vibration frequency of 141 Hz.
Who Else Makes It
Concentrated in Guangdong (14), Zhejiang (2), Tianjin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Dongguan Q & S Electronic Manufacturing Company Limited | Dongguan | Guangdong | Contract manufacturer | 5 |
| Heartland Technology Dongguan Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Tianjin Tairuibosi Medical Appliance Co., Ltd. | Tianjin | Tianjin | Private-label distributor | 30 |
| Ningbo Hanyue Medical Technology Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 27 |
| ALL About Inspired Company Limited | Shanghai | Shanghai | Manufacturer | 12 |
| Shenzhen Linglu Hongtu Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shenzhen S-Hande Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Shenzhen Konmed Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Xi’an Furuize Biotechnology Co., Ltd. | Xi’An | Shaanxi | Manufacturer | 8 |
| Hunan Accurate BIO-Medical Technology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 7 |
| Dongguan Aobo Technology Co., Ltd. | Dongguan | Guangdong | Manufacturer | 7 |
Showing 12 of 21. All 21 manufacturers in China registered for Vibrator For Therapeutic Use, Genital
Record
| Listed by | Hush Tech LLC |
|---|---|
| FDA product code | KXQ |
| Device type | Vibrator For Therapeutic Use, Genital |
| Device class | Class 2 |
| Regulation | 21 CFR 884.5960 |
| Premarket notification | Exempt |
| Record published | 2024-09-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| WAV-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Intimate Rose | Plus EV Holdings Inc | 4 |
| Perifit | X6 Innovations | 3 |
| Sword Bloom | Sword Health S.A. | 2 |
| Meet Blossom | Sword Health S.A. | 1 |
| Fizimed | Fizimed | 1 |
| Silk’n | Home Skinovations, Ltd. | 1 |
| Elvie | Willow Innovations Inc. | 1 |
| Konmed /Pelvifine | Shenzhen Konmed Technology Co., Ltd. | 1 |
| Bloom | Sword Health S.A. | 1 |
| Pelvifine | Shenzhen Konmed Technology Co., Ltd. | 1 |
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.