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Manufacturers
SCM True Air Technologies LLC
Manufacturer Address
SCM True Air Technologies LLC, 7955 National Tpke Unit 100, Louisville KY 40214-4903
Manufacturer Parent Company (2017)
SCM True Air Technologies
Source
USFDA
3 Events
Recall of Device Recall MaXair True Low Air Loss Mattress Replacement System
Recall of Device Recall ECATS E 850 Bariatric Bed
Recall of Device Recall JK Bariatric Beds
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3 devices in the database
Device Recall MaXair True Low Air Loss Mattress Replacement System
Model / Serial
Serial #'s 2054, 2055, 2056, 2057, 2058, 2059, 2060, 2061, 2062, 2063, 2067, 2068, 2069, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2078, 2079, 2080, 2081, 2082, 2083, 2084, 2085, 2086, 2087, 2088, 2089, 2090, 2091, 2092, 2093, 2094, 2095, 2096, 2097, 2100, 2101, 2102, 2103, 2106, 2107, 2108, 2109, 2110, 2111, 2112, 2113, 2114, 2115, 2116, 2126, 2127, 2128, 2129, 2135, 2136, 2137, 2138, 2139, 2118, 2119, 2120, 2122, 2123, 2124, 2125, 2141, 2142, 2143, 2144, 2145, 2146, 2147, 2148, 2149 & 2150.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including GA, KY, and MI.
Product Description
MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc.
Device Recall ECATS E 850 Bariatric Bed
Model / Serial
Serial #'s E510, 506, 503, 515, 518, 10050, 512, 519, E9141, E9150, E9160, E9149, E9137, E5107, E9162, E9165, E9170, E9147, E5323, E520, E9171. E9149, E9516, E9140, 10051, 507, 508, 502, 504, 501, 514, 522, E9139, E10099, E525, 10052, E9148, E9161, E511, E9144, E914, E526, E500, E521, E9166, E530, E529 & E9146.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including GA, KY, and MI.
Product Description
ECATS E 850 Bariatric Bed, True Air Technologies, Inc.
Device Recall JK Bariatric Beds
Model / Serial
Serial #'s 41160, 10127, 09504, 41918, 106800, 62188, 106805, 42331, 106751, 00234A, 62422, 7987, 50147, 7111, 11151100, BB111, 00284A, 2171269, 62383, 4731, 4732, 4733, 4734, 4735
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide Distribution including GA, KY, and MI.
Product Description
JK Bariatric Beds, True Air Technologies, Inc.
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