Johari Digital Healthcare Limited

GUDID 08908008085161

JOHARI DIGITAL HEALTHCARE LIMITED

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 08908008085161
• NIH Device Record Key: f65f6f7a-5a29-4219-bcec-385e8d46edea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Johari Digital Healthcare Limited
• Version Model Number: TENS 250
• 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	08908008085161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K883811

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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 [Johari Digital Healthcare Limited]

• 08908008085246: ISLIM, EMS, 4 Channel, Multiple modes
• 08908008085185: StimTec 2ch/4ch
• 08908008085161: TENS 250
• 08908008085154: AP-439
• 08908008085147: J-STIM2/4
• 08908008085123: STIM3
• 08908008085109: INTERSPEC-IF II
• 08908008085031: JUS2
• 08908008085024: WSU
• 08908008085017: WS2U-Combo Device
• 08908008085000: WS4U-Combo Device