Johari Digital Healthcare Limited

GUDID 08908008085246

ISLIM, EMS, 4 Channel, Multiple modes

JOHARI DIGITAL HEALTHCARE LIMITED

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 08908008085246
• NIH Device Record Key: c4b4390e-6691-4dd2-9c5f-0f270b3fe49c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Johari Digital Healthcare Limited
• Version Model Number: ISLIM
• 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	08908008085246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062439

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

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: 2017-09-11

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