LOOKEE

GUDID 00628176949574

4 CHANNELS TENS, EMS & MASSAGE UNIT

Lookee Tech

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00628176949574
• NIH Device Record Key: 4e073470-62a7-40c2-b62d-6e6c02092aa9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LOOKEE
• Version Model Number: FDES113
• Company DUNS: 240090329
• Company Name: Lookee Tech
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Customer Support Contacts

• Phone: 18182877958
• Email: Support@LookeeTech.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628176949574 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212918

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: 2022-10-10
• Device Publish Date: 2022-09-30

On-Brand Devices [LOOKEE]

• 06281769492150: StimPlus Patch, Transcutaneous electrical nerve stimulator for pain relief
• 10628176949212: LOOKEE LED TENS Unit, StimPlus Patch, Transcutaneous electrical nerve stimulator for pain relief
• 00628176949550: Replacement Pads For LOOKEE® LED TENS Unit - 1 Pack of 3 Pads
• 00628176949567: Upper Arm Blood Pressure Monitor
• 00628176949574: 4 CHANNELS TENS, EMS & MASSAGE UNIT