lecuag

GUDID 06974241370458

Ems Foot Stimulator

Guangzhou Hua Kai Electronic Technology Co., Ltd.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06974241370458
• NIH Device Record Key: 0b73698b-30e4-4c5c-aa9a-67adbfa146c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: lecuag
• Version Model Number: HK701
• Company DUNS: 528170971
• Company Name: Guangzhou Hua Kai Electronic 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	06974241370458 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221251

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-02
• Device Publish Date: 2023-01-17

On-Brand Devices [lecuag]

• 06974241370540: Ems Foot Stimulator
• 06974241370519: Ems Foot Stimulator
• 06974241370489: Ems Foot Stimulator
• 06974241370458: Ems Foot Stimulator