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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K032731
Device Name MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS
Applicant
Turbo Wheelchair Co., Inc.
76 Meridian Rd.
Beaufort,  SC  29907
Applicant Contact JANE HERMES
Correspondent
Turbo Wheelchair Co., Inc.
76 Meridian Rd.
Beaufort,  SC  29907
Correspondent Contact JANE HERMES
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/03/2003
Decision Date 10/30/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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