Modpod

Basic Information

• Brand Name: Modpod
• Primary DI: 00853096004151
• Version / Model: 12.1000
• Catalog Number: 12.1000
• Company Name: HOLLYWOG, LLC
• Labeler DUNS: 043450879
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 5
• Public Version Date: 2021-08-30
• Public Version Status: Update
• Public Device Record Key: d01f5ea8-a60f-49c7-a33a-195ca1d48268
• Distribution End Date: 2019-06-30

Device Description

Modpod brand powered, static/intermittent, mobile traction system

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITH	Equipment, Traction, Powered	Physical Medicine	890.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45538	Static/intermittent powered traction system, mobile	An assembly of devices designed to apply continuous and/or various intermittent (regular, progressive/regressive, cycled) traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. It is designed to be placed on a trolley (cart) that can be rolled to a table or chair to apply horizontal or vertical traction. It usually consists of an AC-powered motor with a control unit used to generate and regulate the mechanical forces, and a cord clamped to harnesses to transmit the force. Adjustable spreader bars attached to the control unit may be used to vary the angle at which the cord applies traction. It is used primarily to widen intervertebral spaces.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10853096004158	GS1	shipper box	1	Not in Commercial Distribution	2019-06-30
Primary	00853096004151	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K150695	000

Device Sizes

Type	Value	Unit	Text
Width	39.4	Centimeter
Length	76.8	Centimeter
Height	27.9	Centimeter

Storage Conditions

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