H-Wave

GUDID 00869844000221

Powered Muscle Stimulator

ELECTRONIC WAVEFORM LAB, INC

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00869844000221
• NIH Device Record Key: 55cb66d3-9aea-4713-a794-1ae13af602bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H-Wave
• Version Model Number: HWOTC
• Company DUNS: 065105561
• Company Name: ELECTRONIC WAVEFORM LAB, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com
• Phone: 714-843-0463
• Email: contact@h-wave.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869844000221 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160255

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-12-05

On-Brand Devices [H-Wave]

• 00869844000221: Powered Muscle Stimulator
• 00869844000207: Powered Muscle Stimulator