easy@Home TENS AND MUSCLE STIMULATOR

GUDID 00810038637365

easy@Home TENS AND MUSCLE STIMULATOR

EASY HEALTHCARE CORPORATION

Hand-held electric massager

• Primary Device ID: 00810038637365
• NIH Device Record Key: e95e44e7-a5b9-4442-84ad-ed5b06af3205
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: easy@Home TENS AND MUSCLE STIMULATOR
• Version Model Number: EHE080
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038636047 [Previous]
GS1	00810038637365 [Primary]
GS1	10810038637362 [Package]; Package: carton [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200727

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-25
• Device Publish Date: 2025-04-17

On-Brand Devices [easy@Home TENS AND MUSCLE STIMULATOR]

• 10810038636044: EHE080
• 00810038637365: easy@Home TENS AND MUSCLE STIMULATOR