DALTON TACAHE HEAVY DUTY POWERCHAIR

GUDID 00815027011393

TACAHE HEAVY DUTY POWERCHAIR, RED, WT. LIMIT 600 LBS.

DALTON MEDICAL CORPORATION

Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible Wheelchair, power-assisted, occupant-controlled, collapsible

• Primary Device ID: 00815027011393
• NIH Device Record Key: 87527d24-79b3-4b74-98ce-6ead77f6a198
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DALTON TACAHE HEAVY DUTY POWERCHAIR
• Version Model Number: PC-P710VAR
• Company DUNS: 874709348
• Company Name: DALTON MEDICAL CORPORATION
• 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: 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: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815027011393 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052534

FDA Product Code

• ITI: Wheelchair, 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-11

On-Brand Devices [DALTON TACAHE HEAVY DUTY POWERCHAIR]

• 00815027011768: TACAHE HEAVY DUTY POWERCHAIR, BLUE, WT. LIMIT 475 LBS.
• 00815027011751: TACAHE HEAVY DUTY POWERCHAIR, RED, WT. LIMIT 475 LBS.
• 00815027011409: TACAHE HEAVY DUTY POWERCHAIR, BLUE, WT. LIMIT 600 LBS.
• 00815027011393: TACAHE HEAVY DUTY POWERCHAIR, RED, WT. LIMIT 600 LBS.
• 00815027010686: TACAHE MID-WHEEL DRIVE HEAVY DUTY POWERCHAIR, BLUE, WT. LIMIT 450 LBS.
• 00815027010679: TACAHE MID-WHEEL DRIVE HEAVY DUTY POWERCHAIR, RED, WT. LIMIT 450 LBS.