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510(k) Data Aggregation
K Number
K193599Device Name
BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair
Manufacturer
Date Cleared
2020-09-03
(255 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
21st Century Scientific, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The indication for use of the BOUNDER Power Wheelchair is to provide mobility to persons limited to a sitting position.
Device Description
The subject device is an update to the existing previously cleared BOUNDER Power Wheelchair (K901210). The BOUNDER utilizes components found on most power wheelchairs. These include a rigid or "nonfolding", rear wheel drive power wheelchair base with two drive wheels in the rear with two anti-tip wheels mounted behind and two casters in the front. It has two motors and is powered by two 12V DC Batteries (connected in series), and electronic controller. It also includes a seat, footrests, arms, positioning strap and charger. The design offers a modular approach and can be configured in multiple versions to suit different user needs.
The new models will include: BOUNDER 300, BOUNDER Plus 300, BOUNDER 450, BIG BOUNDER 600 & BIG BOUNDER 1000.
The updated subject version of the BOUNDER Power Wheelchair has the following changes:
- Increase in the weight capacity of the previously cleared device from 500 lb to 1000 lb
- Add Power Tilt, Power Anterior Tilt, Power Recline and Power Seat Elevator options
- Addition of LiNX and R-net electronics
- Add Independent Drive Wheel Suspension
- Add an Off-Road tire option for BOUNDER 300, BOUNDER Plus 300 and BOUNDER 450
- Top speed: 8.5 mph
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