WAVE WAV-01

GUDID 00860012112500

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.

Hush Tech LLC

Pelvic floor internal manual massager

• Primary Device ID: 00860012112500
• NIH Device Record Key: 212257b9-a638-4885-aa3e-62c80149f60b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WAVE
• Version Model Number: WAV-01
• Catalog Number: WAV-01
• Company DUNS: 068853354
• Company Name: Hush Tech LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc
• Phone: (917) 672-6457
• Email: Info@Hush.llc

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860012112500 [Primary]

FDA Product Code

• KXQ: Vibrator For Therapeutic Use, Genital

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-09
• Device Publish Date: 2024-09-01