Modpod 12.1000

GUDID 10853096004158

Modpod brand powered, static/intermittent, mobile traction system

HOLLYWOG, LLC

Static/intermittent powered traction system, mobile

• Primary Device ID: 10853096004158
• NIH Device Record Key: d01f5ea8-a60f-49c7-a33a-195ca1d48268
• Commercial Distribution Discontinuation: 2019-06-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Modpod
• Version Model Number: 12.1000
• Catalog Number: 12.1000
• Company DUNS: 043450879
• Company Name: HOLLYWOG, 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: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 4233057778
• Email: info@hollywog.com
• Phone: 4233057778
• Email: info@hollywog.com
• Phone: 4233057778
• Email: info@hollywog.com
• Phone: 4233057778
• Email: info@hollywog.com
• Phone: 4233057778
• Email: info@hollywog.com
• Phone: 4233057778
• Email: info@hollywog.com
• Phone: 4233057778
• Email: info@hollywog.com
• Phone: 4233057778
• Email: info@hollywog.com
• Phone: 4233057778
• Email: info@hollywog.com
• Phone: 4233057778
• Email: info@hollywog.com

Device Dimensions

• Height: 27.9 Centimeter
• Height: 27.9 Centimeter
• Height: 27.9 Centimeter
• Width: 39.4 Centimeter
• Length: 76.8 Centimeter
• Height: 27.9 Centimeter
• Width: 39.4 Centimeter
• Length: 76.8 Centimeter
• Height: 27.9 Centimeter
• Width: 39.4 Centimeter
• Length: 76.8 Centimeter
• Height: 27.9 Centimeter
• Width: 39.4 Centimeter
• Length: 76.8 Centimeter
• Height: 27.9 Centimeter
• Width: 39.4 Centimeter
• Length: 76.8 Centimeter
• Height: 27.9 Centimeter
• Width: 39.4 Centimeter
• Length: 76.8 Centimeter
• Height: 27.9 Centimeter
• Width: 39.4 Centimeter
• Length: 76.8 Centimeter
• Height: 27.9 Centimeter
• Width: 39.4 Centimeter
• Length: 76.8 Centimeter
• Height: 27.9 Centimeter
• Width: 39.4 Centimeter
• Length: 76.8 Centimeter
• Height: 27.9 Centimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 60 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 160 Degrees Fahrenheit
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853096004151 [Primary]
GS1	10853096004158 [Package]; Contains: 00853096004151; Package: shipper box [1 Units]; Discontinued: 2019-06-30; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150695

FDA Product Code

• ITH: Equipment, Traction, 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: 2019-10-31
• Device Publish Date: 2016-09-20

Devices Manufactured by HOLLYWOG, LLC

• 00853096004014 - WiTouch: 2019-10-31 WiTouch brand over the counter transcutaneous electrical nerve simulator for analgesic pain relief in the lower back
• 00853096004083 - Neubac: 2019-10-31 Neubac brand of over the counter transcutaneous electrical nerve stimulator for analgesic pain relief in the lower back.
• 10853096004158 - Modpod: 2019-10-31Modpod brand powered, static/intermittent, mobile traction system
• 10853096004158 - Modpod: 2019-10-31 Modpod brand powered, static/intermittent, mobile traction system
• 00853096004021 - WiTouch Pro: 2019-10-23 WiTouch brand over the counter transcutaneous electrical nerve simulator to be used for temporary relief of pain associated with