Equate

GUDID 16972759470001

TENS & EMS Device

Jiangxi Royall Smart Technology Co., Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 16972759470001
• NIH Device Record Key: e7ddde3c-4e19-45c7-b97c-5d061085a46b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equate
• Version Model Number: LY-ET-01
• Company DUNS: 554514493
• Company Name: Jiangxi Royall Smart Technology Co., Ltd.
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972759470004 [Primary]
GS1	16972759470001 [Package]; Contains: 06972759470004; Package: [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230443

FDA Product Code

• NYN: Stimulator, Electrical, Transcutaneous, For Arthritis

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: 2023-07-07
• Device Publish Date: 2023-06-29