Transcutaneous Electrical Nerve Stimulators

GUDID 06924607702461

Shenzhen Kentro Medical Electronics Co.,Ltd

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 06924607702461
• NIH Device Record Key: 42e8f798-09d6-4c94-b46e-af722f8f2ebb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Transcutaneous Electrical Nerve Stimulators
• Version Model Number: KTR-2651
• 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: false
• 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	06924607702461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200177

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: 2021-12-15
• Device Publish Date: 2021-12-07

On-Brand Devices [Transcutaneous Electrical Nerve Stimulators]

• 06924607702461: KTR-2651
• 06924607702454: KTR-2650
• 06924607702447: KTR-2642
• 06924607702430: KTR-2641
• 06924607702393: KTR-2610
• 06924607702614: KTR-2342
• 06924607702607: KTR-2341
• 06924607702577: KTR-2494
• 06924607702560: KTR-2493
• 06924607702553: KTR-2492
• 06924607702546: KTR-2491
• 06924607702539: KTR-2412
• 06924607702522: KTR-2411
• 06924607702515: KTR-2402
• 06924607702508: KTR-2401
• 06924607702492: KTR-2302
• 06924607702485: KTR-2301
• 06924607702478: KTR-2652
• 06924607702423: KTR-2640
• 06924607702416: KTR-2612
• 06924607702409: KTR-2611
• 06924607702386: KTR-2252
• 06924607702379: KTR-2251
• 06924607702362: KTR-2250
• 06924607702355: KTR-2242
• 06924607702348: KTR-2241
• 06924607702331: KTR-2240
• 06924607702324: KTR-2232
• 06924607702317: KTR-2231
• 06924607702300: KTR-2230
• 06924607702294: KTR-2222
• 06924607702287: KTR-2221
• 06924607702270: KTR-2220
• 06924607702263: KTR-2212
• 06924607702256: KTR-2211
• 06924607702249: KTR-2210