Easy@Home TENS AND MUSCLE STIMULATOR

GUDID 10810038636044

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 10810038636044
• NIH Device Record Key: d27d6797-7ab8-4576-bd00-ef8dbae15218
• 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 [Primary]
GS1	10810038636044 [Package]; Contains: 00810038636047; Package: [36 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143268

FDA Product Code

• NUH: Stimulator, Nerve, Transcutaneous, Over-The-Counter

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: 2024-01-29
• Device Publish Date: 2024-01-20

Devices Manufactured by EASY HEALTHCARE CORPORATION

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• 10810038635702 - Easy@Home Pregnancy Test (3 tests): 2024-02-05 Easy@Home Pregnancy Test (3 tests)
• 10810038635719 - Easy@Home Pregnancy Test (5 tests): 2024-02-05 Easy@Home Pregnancy Test (5 tests)
• 10810038636044 - Easy@Home TENS AND MUSCLE STIMULATOR: 2024-01-29
• 10810038636044 - Easy@Home TENS AND MUSCLE STIMULATOR: 2024-01-29
• 30810038634754 - Easy@home Feminine Vaginal pH Test Strip(30 tests): 2023-08-10 Easy@home Feminine Vaginal pH Test Strip(30 tests)
• 30810038634761 - Easy@home Feminine Vaginal pH Test Strip(10 tests): 2023-08-10 Easy@home Feminine Vaginal pH Test Strip(10 tests)
• 30810038634655 - Areta Cotinine Test Strip -COT(10 tests one kit): 2023-07-27 10 tests kit; COT Single Drug Screen Test