Home Care

GUDID 04719873683208

EMS (Electronic Muscle Stimulator)

HOME CARE TECHNOLOGY CO., LTD.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04719873683208
• NIH Device Record Key: 6cbdf4e9-870e-409d-a514-24e60845037f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Home Care
• Version Model Number: HT 311
• Company DUNS: 658105861
• Company Name: HOME CARE 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873683208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022998

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-12-31

On-Brand Devices [Home Care]

• 04719873684755: Transcutaneous electrical stimulation electrode
• 04719873684724: Transcutaneous electrical stimulation electrode
• 04719873684557: Electroconductive(Electrode Gel)
• 04719873684540: Electroconductive (Electrode Gel)
• 04719873684328: Transcutaneous electrical stimulation electrode
• 04719873683338: EMS (Electronic Muscle Stimulator)
• 04719873683321: EMS (Electronic Muscle Stimulator)
• 04719873683314: EMS (Electronic Muscle Stimulator)
• 04719873683307: EMS (Electronic Muscle Stimulator)
• 04719873683215: EMS (Electronic Muscle Stimulator)
• 04719873683208: EMS (Electronic Muscle Stimulator)