Powered Muscle Stimulator

GUDID 06924607701242

Shenzhen Kentro Medical Electronics Co.,Ltd

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 06924607701242
• NIH Device Record Key: 14fc731b-2236-47c8-a102-5384685c7bc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Powered Muscle Stimulator
• Version Model Number: KTR-230B
• Company DUNS: 544395368
• Company Name: Shenzhen Kentro Medical Electronics Co.,Ltd
• 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: true
• 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	06924607701242 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181728

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: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-01-11

On-Brand Devices [Powered Muscle Stimulator]

• 06924607701280: KTR-234
• 06924607701273: KTR-233
• 06924607701266: KTR-232
• 06924607701259: KTR-231
• 06924607701242: KTR-230B
• 06924607701235: KTR-230P
• 06924607701228: KTR-230W