Neurotech Kneehab

GUDID 00850372007141

KNEEHAB PLUS GARMENT EXTENDER KIT

THERAGEN, LLC

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 00850372007141
• NIH Device Record Key: 56851535-241d-4e5f-9bd6-bd51d4af92d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neurotech Kneehab
• Version Model Number: 0411-5038
• Company DUNS: 080028759
• Company Name: THERAGEN, LLC
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850372007141 [Primary]

FDA Product Code

• IPF: Stimulator, Muscle, Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-12-05

On-Brand Devices [Neurotech Kneehab]

• 00850372007141: KNEEHAB PLUS GARMENT EXTENDER KIT
• 00850372007127: KNEEHAB PLUS SMALL CONDUCTIVE GEL PADS USA
• 00850372007110: KNEEHAB CONDUCTIVE GEL PADS US
• 00850372007066: KNEEHAB+ TENS PROGRAMMED CABLE PACK
• 00850372007059: KNEEHAB PLUS SMALL GARMENT US LEFT
• 00850372007042: KNEEHAB PLUS SMALL GARMENT US RIGHT
• 00850372007035: KNEEHAB PLUS GARMENT US LEFT
• 00850372007028: KNEEHAB PLUS GARMENT US RIGHT
• 00850372007004: Neurotech Kneehab NMES+TENS Controller.