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K Number
K082288
Device Name
HAIDA HD21
Manufacturer
JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD.
Date Cleared
2008-08-19

(8 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
PM
Reference & Predicate Devices
K062888,K072027
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

HAIDA HD21 powered wheelchair is intended for an indoor/outdoor power wheelchair that provides transportation for disabled or elderly persons limited to a seated position.

It is a motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Device Description

The HAIDA HD21 powered wheelchair is an indoor/outdoor powered wheelchair that is battery operated. The design of this wheelchair is basically similar to other powered wheelchairs that are already on the market.

AI/ML Overview

The provided text is a 510(k) summary for a powered wheelchair (HAIDA HD21). It does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The document primarily focuses on:

  • Device Identification: Trade name, common name, classification, and product code.
  • Predicate Devices: Identifying similar devices already on the market (CWD01 and KV10HB).
  • Intended Use: Describing the purpose of the powered wheelchair.
  • Device Description: Briefly outlining the design as similar to existing powered wheelchairs.
  • Substantial Equivalence: Stating that the HAIDA HD21 is substantially equivalent to the predicate devices and that any minor differences do not raise new safety or effectiveness concerns.
  • FDA 510(k) Clearance Letter: Formal approval from the FDA based on the substantial equivalence claim.
  • Indications for Use Statement: Detailed description of how the device is intended to be used.

Since the provided text does not describe an active study or acceptance criteria, I cannot fill out the requested table and information. This kind of information is typically found in a "Performance Data" or "Clinical Data" section of a 510(k) submission, which is not present in the provided excerpts.

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).