WAVE

Primary DI
00860012112500
Brand
WAVE
Company
Hush Tech LLC
Model
WAV-01
Catalog number
WAV-01
Device description
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.
Published
2024-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXQVibrator For Therapeutic Use, Genital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXQVibrator For Therapeutic Use, GenitalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012112500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012112500008600121125008600121125000860012112500

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic floor internal manual massagerA manual (non-powered) device intended to be inserted into the rectum or vagina and manipulated to massage myofascial trigger points of the pelvic floor muscles to relieve acute or chronic pelvic pain (e.g., myofascial pelvic pain syndrome). It is in the form of a design-shaped plastic wand and is intended to be used with disposable coverings (not included) and a water-based lubricant (not included). This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(917) 672-6457Info@Hush.llc

Regulatory Flags#

DUNS number
068853354
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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06970935830710PelvifineShenzhen Konmed Technology Co., Ltd.KXQ2025-02-18
05065013876047Meet BlossomSWORD HEALTH, S.A.KXQ2024-12-23
05065013876054Meet BlossomSWORD HEALTH, S.A.KXQ2024-12-23
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00850005838395Intimate RosePLUS EV HOLDINGS INC.KXQ2024-12-10
00850005838432Intimate RosePLUS EV HOLDINGS INC.KXQ2024-12-10
05065013876023Sword BloomSWORD HEALTH, S.A.KXQ2024-07-25
05065013876030Sword BloomSWORD HEALTH, S.A.KXQ2024-07-25
05600775530563BloomSWORD HEALTH, S.A.KXQ2023-09-07
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03770014642004PerifitX6 INNOVATIONSKXQ2021-08-03
03770014642226PerifitX6 INNOVATIONSKXQ2021-06-15
07109615470598PerifitX6 INNOVATIONSKXQ2021-06-15
17290112450064Silk'nHOME SKINOVATIONS LTDKXQ2018-11-04
07290112450067Silk'nHOME SKINOVATIONS LTDKXQ2018-11-04
05060442520004ElvieWILLOW INNOVATIONS, INC.KXQ2018-05-03