MEDACURE

GUDID 00853223008106

WINGS

MEDACURE INC.

Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible

• Primary Device ID: 00853223008106
• NIH Device Record Key: a18a251d-3c87-4c1b-8fe2-704bdb67d9a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDACURE
• Version Model Number: PW2018
• Company DUNS: 079352467
• Company Name: MEDACURE INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853223008106 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070501

FDA Product Code

• ITI: Wheelchair, Powered

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-15

On-Brand Devices [MEDACURE]

• 00869201000260: OASIS
• 00869201000253: PRO DYNAMIC
• 00869201000246: LINCOLN
• 00869201000239: AMERICAN SPIRIT
• 00869201000222: COMFORT ZONE
• 00869201000215: COMFORT ZONE
• 00869201000208: ALTERPEUTIC
• 00853223008267: ULTRA LOW BED
• 00853223008250: AMERICAN SPIRIT
• 00853223008236: COMFORT ZONE
• 00853223008229: LINCOLN
• 00853223008212: LINCOLN
• 00853223008205: ULTRA LOW BED
• 00853223008199: AMERICAN SPIRIT
• 00853223008182: ULTRA LOW BED
• 00853223008175: ULTRA LOW BED
• 00853223008168: COMFORT ZONE
• 00853223008151: COMFORT ZONE
• 00853223008144: COMFORT ZONE
• 00853223008137: COMFORT ZONE
• 00853223008120: AIR WAVE
• 00853223008113: ALTERPEUTIC
• 00853223008106: WINGS
• 00853223008090: LINCOLN
• 00853223008083: AIR STREAM
• 00853223008076: AIR STREAM
• 00853223008069: ULTRA LOW BED
• 00853223008014: FREE SPIRIT
• 00853223008007: COMFORT ZONE
• 00853223008298: BUBBLE PAD MATTRESS SYSTEM
• 00853223008311: ALTERNATING PRESSURE MATTRESS 36” X 80” WITH PUMP
• 00853223008304: ALTERNATING PRESSURE MATTRESS 36” X 80” WITH PUMP
• 00853223008342: ALTERNATING PRESSURE MATTRESS 36” X 80” WITH PUMP
• 00853223008335: ULTRA LOW 4 FUNCTION EXTEND-A-BED
• 00853223008328: ULTRA LOW 4 FUNCTION BED
• 00853223008052: ALTER LIGHT
• 00853223008045: ALTER LIGHT
• 00853223008038: ALTER LIGHT
• 00853223008021: ALTER LIGHT
• 00853223008410: ROLLATOR BARIATRIC- 500 LBS.
• 00853223008403: COMMODE BARIATRIC - 1,000 LBS.
• 00853223008397: COMMODE BARIATRIC - 650 LBS.
• 00853223008380: GERI CHAIR - BARIATRIC - 500 LBS.
• 00853223008373: WINGS BARIATRIC WHEELCHAIR - 30"
• 00853223008366: WINGS BARIATRIC WHEELCHAIR - 28"
• 00853223008359: WINGS BARIATRIC WHEELCHAIR - 26"