Flex-TENS Retail

GUDID 00858688006087

(device + electrodes)

Emsi

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: 00858688006087
• NIH Device Record Key: 6f0ff5c8-8d4d-4a98-80fb-e8067be911c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex-TENS Retail
• Version Model Number: FLET0001R
• Company DUNS: 932471881
• Company Name: Emsi
• 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: false
• Serial Number: true
• 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	00858688006087 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071869

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: 2016-09-02

Devices Manufactured by Emsi

• 00858688006964 - Electrode 45 x 45 16 PK: 2023-09-28
• 00858688006971 - Electrode 1.75 x 1.75 4 pack: 2023-09-28
• 00859718007074 - Electrode 1.75 x 1.75 - 24 PK: 2023-09-28
• 00859718007081 - Electrode 4.0 x 7.0- Dispersive: 2023-09-28
• 00859718007098 - Electrode 1 Inch Round 4 PK: 2023-09-28
• 00859718007104 - Electrode 2" round 4pk: 2023-09-28
• 00859718007111 - Electrode 3 Inch Round 4PK: 2023-09-28
• 00859718007135 - Electrode 2 x 4 Inch Rectangle: 2023-09-28