G.LAB

GUDID 00853455007076

ACESO HEALTHCARE PRODUCTS, INC.

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00853455007076
• NIH Device Record Key: ffac5906-e9b6-468c-bccb-72d5b1eca7ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: G.LAB
• Version Model Number: PR0100
• Company DUNS: 058430522
• Company Name: ACESO HEALTHCARE PRODUCTS, INC.
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853455007076 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152374

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: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-02-12

On-Brand Devices [G.LAB]

• 00853455007083: PR0200
• 00853455007076: PR0100
• 00853455007007: MD4180
• 00853455007151: MD2222
• 00853455007144: MD1180
• 00853455007113: MD2200
• 00853455007106: MD41W1
• 00853455007090: MD41W0