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510(k) Data Aggregation
K Number
K011752Device Name
GOVAN+ WHEELCHAIR AND DOCKING ACCESSORY
Manufacturer
Date Cleared
2001-06-28
(22 days)
Product Code
Regulation Number
890.3850Why did this record match?
Applicant Name (Manufacturer) :
ACCUFAST, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Therapeutic effect:
- Provision of out-of-bed seating for disabled persons.
- Transportation of disabled persons from one location to another in a room or in a building or outdoors.
- Transportation of disabled persons in the device in motor vehicles.
Medical conditions for which the device is indicated:
- Post-operative weakness or debility.
- Age-related weakness or debility.
- Paralysis due to stroke, tumour, etc.
- Impairment of function due to MS, ALS, Polio.
- Impairment from physical trauma.
- Impairment from accidents at birth.
Device Description
Designed to remedy perceived shortfalls in the design of standard wheelchairs, particularly in the category of user safety, the GOVAN+ device's distinctive appearance confirms that it is not meant to be a duplicate of the predicate device.
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