Zewa

GUDID 00682891210050

TENS Unit Digital

ZEWA, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00682891210050
• NIH Device Record Key: a8408b8d-9e58-488a-bcb5-ce13ea700d47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zewa
• Version Model Number: 21005
• Company DUNS: 013481078
• Company Name: ZEWA, 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682891210050 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100399

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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: 2016-09-05

On-Brand Devices [Zewa]

• 00682891391001: BP Monitor UAM-910BT
• 00682891390004: BP Monitor
• 00682891388070: BP Monitor
• 00682891388018: BP Monitor
• 00682891388001: BP Monitor
• 00682891383013: BP Monitor
• 00682891383006: BP Monitor
• 00682891372000: BP Monitor
• 00682891371003: BP Monitor UAM-710
• 00682891338006: Wrist BP Monitor
• 00682891210678: Electrodes 2"x3.5" (4pcs.)
• 00682891210647: Mini Go Replacement Electrodes
• 00682891210593: Electrodes Deluxe 3.5"x5" (4pcs.)
• 00682891210579: Electrodes Belt (4pcs.)
• 00682891210555: Electrodes Deluxe 2"x2" (4pcs.)
• 00682891210517: Electrodes 2"x2" (8pcs.)
• 00682891210500: Electrodes Deluxe 2"x2" (8pcs.)
• 00682891210494: Electrodes Deluxe 2"x2" (4pcs.)
• 00682891210487: Electrodes 2"x2" (4pcs.)
• 00682891210227: TENS Unit 21022
• 00682891210197: SpaBuddy Sport
• 00682891210173: SpaBuddy Relax
• 00682891210104: TENS Unit Combo
• 00682891210074: TENS Unit Analog
• 00682891210050: TENS Unit Digital
• 00682891210043: TENS Unit Analog
• 00682891382009: BP Monitor UAM-820BT
• 00682891216007: Pulse Ox
• 00682891216014: Pulse Ox
• 00682891111104: Infrared Thermometer
• 00682891390103: BP Monitor
• 00682891213006: Scale
• 00682891395009: BP Monitor UAM-950
• 00682891111159: Infrared Thermometer
• 00682891365552: Compressor Nebulizer
• 00682891216021: Pulse Ox OTC
• 00682891216090: Pulse Ox RX