Pain Aide K-PA

GUDID 05033435132232

Pain Aide is a TENS device which is commonly used to provide relief from pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. It has four preset programs specially designed to alleviate pain in different parts of the body. Pain Aide is designed to be easy to use, but has professional grade features like small 1 mA intensity steps, open-circuit detection with cutout, automatic keypad locking, and back-lit display. It uses standard AA batteries and self-adhesive electrode pads. Garment glove and sock electrodes are available as optional extras.

TENSCARE LIMITED

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 05033435132232
• NIH Device Record Key: 4bf39cb9-f214-486e-83d6-f2581feb6fc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pain Aide
• Version Model Number: 1
• Catalog Number: K-PA
• Company DUNS: 569403736
• Company Name: TENSCARE LIMITED
• 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: 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800 308 7390
• Email: compliance@tenscare.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05033435132232 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140168

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-11-12

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