Seven Seas Distribution and Manufacturing,LLC

GUDID 08908008085239

JOHARI DIGITAL HEALTHCARE LIMITED

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 08908008085239
• NIH Device Record Key: 9c9b9819-00a6-4bd8-baa6-26f46747e3a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Seven Seas Distribution and Manufacturing,LLC
• Version Model Number: PRO-TECH MULTI STIM
• Company DUNS: 675938472
• Company Name: JOHARI DIGITAL HEALTHCARE LIMITED
• 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: false
• Serial Number: true
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908008085239 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024036

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: 2016-09-19

On-Brand Devices [Seven Seas Distribution and Manufacturing,LLC]

• 08908008085239: PRO-TECH MULTI STIM
• 08908008085048: X FORCE