Zewa

GUDID 00682891210074

TENS Unit Analog

ZEWA, INC.

Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00682891210074
• NIH Device Record Key: 24ecb67c-9199-446b-a7f5-4051380976ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zewa
• Version Model Number: 21007
• 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	00682891210074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002874

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