SuperStand Standing Wheelchair

GUDID B289PS2

Full-power, power to drive and power to stand, standing wheelchair

STANDING COMPANY, THE

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

• Primary Device ID: B289PS2
• NIH Device Record Key: bf3d0f7c-6ef4-4932-983c-d6f337b9798c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SuperStand Standing Wheelchair
• Version Model Number: PS-2
• Company DUNS: 557086410
• Company Name: STANDING COMPANY, THE
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B289PS2 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032101

FDA Product Code

• IPL: Wheelchair, Standup

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: 2016-09-24

On-Brand Devices [SuperStand Standing Wheelchair]

• B289SS1F0: Superstand Standing Wheelchair, manual, folding
• B289PS2: Full-power, power to drive and power to stand, standing wheelchair
• B289HPS2: Half-Power, power to drive, manual to stand, standing wheelchair