WAVE

Basic Information

• Brand Name: WAVE
• Primary DI: 00860012112500
• Version / Model: WAV-01
• Catalog Number: WAV-01
• Company Name: Hush Tech LLC
• Labeler DUNS: 068853354
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-01
• Public Version: 1
• Public Version Date: 2024-09-09
• Public Version Status: New
• Public Device Record Key: 212257b9-a638-4885-aa3e-62c80149f60b

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXQ	Vibrator For Therapeutic Use, Genital	Obstetrics/Gynecology	884.5960	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65044	Pelvic floor internal manual massager	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860012112500	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]