Pure Enrichment

GUDID 04719880810192

HIVOX BIOTEK INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 04719880810192
• NIH Device Record Key: 8f7f21fb-b2a3-4dc6-ae87-3e89774468e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pure Enrichment
• Version Model Number: FT-240
• Company DUNS: 658030473
• Company Name: HIVOX BIOTEK 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: true
• Expiration Date: true
• 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	04719880810192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221384

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-06
• Device Publish Date: 2022-06-28

Devices Manufactured by HIVOX BIOTEK INC.

• 04719880810192 - Pure Enrichment: 2022-07-06
• 04719880810192 - Pure Enrichment: 2022-07-06
• 04719880810123 - TENS MAKER: 2022-03-30
• 04719880810147 - TENS MAKER: 2022-02-21
• 04719880810154 - TENS MAKER: 2022-02-21
• 04719880810000 - TENS MAKER: 2021-06-03