Nu Skin RenuSpa iO

GUDID 00850021097554

NSE PRODUCTS, INC.

Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 00850021097554
• NIH Device Record Key: ae783f2e-0d71-4be7-a61a-90619972ea71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nu Skin RenuSpa iO
• Version Model Number: BS2RM
• Company DUNS: 803486393
• Company Name: NSE PRODUCTS, INC.
• 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: false
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850021097554 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232001

FDA Product Code

• NFO: Stimulator, transcutaneous electrical, aesthetic purposes

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: 2023-12-05
• Device Publish Date: 2023-11-27

Devices Manufactured by NSE PRODUCTS, INC.

• 00850021097554 - Nu Skin RenuSpa iO: 2023-12-05
• 00850021097554 - Nu Skin RenuSpa iO: 2023-12-05
• 00850021097561 - Nu Skin RenuSpa iO Package: 2023-12-05
• 00850021097578 - AP 24® Smile Pop Toothbrush: 2023-08-21
• 00860196000303 - Nu Skin Facial Spa: 2019-10-23
• 00860196000327 - Nu Skin Facial Spa Package: 2019-10-23
• 00860196000310 - Nu Skin Conductive Gel: 2018-07-06