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Devices
Device Recall Karma
Model / Serial
Item # 935-0245H6 Flexx (KM852216) Serial # TM14-A03982-TM14-A03991 Item # 935-0246H6 Flexx (KM852218) Serial # TM14-A03992-TM14-A04012 Item # 935-0247H6 Flexx (KM852220) Serial # TM14-A4013-TM14-A04017
Product Classification
Physical Medicine Devices
Device Class
1
Implanted device?
No
Distribution
U.S. distribution to the following states -- WA, CA, NY, and TX.
Product Description
Karma Flexx Wheelchair || Manual Wheelchair.
Manufacturer
Karman Healthcare Inc
1 Event
Recall of Device Recall Karma
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Manufacturer
Karman Healthcare Inc
Manufacturer Address
Karman Healthcare Inc, 19255 San Jose Ave, City of Industry CA 91748-1418
Manufacturer Parent Company (2017)
Karman Healthcare Inc
Source
USFDA
Language
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