Intimd

GUDID 04719871185575

Electrical Muscel Stimulator (EMS)

EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04719871185575
• NIH Device Record Key: 5c0d9650-4a3f-4287-96fe-66fd90987719
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intimd
• Version Model Number: KWELL EM1
• Company DUNS: 657383535
• Company Name: EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719871185575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213116

FDA Product Code

• KPI: Stimulator, Electrical, Non-Implantable, For Incontinence

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: 2022-04-22
• Device Publish Date: 2022-04-14

Devices Manufactured by EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

• 04719871185841 - iSTIM: 2024-09-19 HEATING TENS/EMS
• 04719871185858 - iSTIM: 2024-09-19 HEATING TENS
• 04719871183892 - MEDI-STIM: 2024-03-25 Transcutaneous Electrical Nerve Stimulator (T.E.N.S.)
• 04719871184073 - Everyway: 2023-09-07 Cutaneous Electrode Pad
• 04719871184103 - Everyway: 2023-09-07 Cutaneous Electrode Pad
• 04719871184455 - Everyway: 2023-09-07 Electrical Muscel Stimulator (EMS)
• 04719871189108 - iSTIM: 2023-09-07 Incontinence probe Perineal orifice incontinence-control electrical stimulation system electrode
• 04719871189184 - Everyway: 2023-09-07