Devices

Device Recall Hydrospa Capsules

  • 모델명 / 제조번호(시리얼번호)
    PART E30007 SERIAL NUMBERS: G20601042211, G206035726, G2070352502, G206034722, G206054897, G206064937, G206064948, G206065935, G206075975, G2070142370, G2070152369, G2070152379, G2070542647, G2060742004, G2061152227, G2061152295, G2070242438, G2070242445, G2070242456, G2070252439, G2070252459 and G2070242457; and  PART E30007-01 SERIAL NUMBERS:  G206074977, G2060952073, G2060942062 and G2060952069; and  PART E30007-100 SERIAL NUMBERS:  G2070142380 and G2070152372; and  PART E30007-200 SERIAL NUMBER:  G2070242466.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US including states of CA, IA, MN, NE, NJ, NY, TX and WA and countries of Macedonia, Hungary, Greece, South Africa, Italy, Hong Kong, United Arab Emirates, Greece, Croatia, Australia, Kuwait, Turkey, Mexico, Belgium, England, Barbados, France, Japan, Lebanon, Moldova, Poland, Portugal, Romania, Russia, Spain and Thailand.
  • 제품 설명
    DERMALIFE Spa Feng Shui 2G. Part #E30007-100 is: Spa-Feng Shui 2G;100V 50/60Hz. This is the Spa Feng Shui product without the 2 optional pedestals which the unit can sit on top of, in a 100V version which was produced specifically for our Japanese consignee to meet Japan's specialized 100V electrical requirements. || Part #E30007-200 is: Spa-Feng Shui 2G;200V 50/60Hz. This is the Spa Feng Shui product without the 2 optional pedestals which the unit can sit on top of, in a 200V version which was produced specifically for our Japanese consignee to meet Japan's specialized 200V electrical requirements. || Part #E30007-01 - Feng Shui 2G; Assay w/Pedestal. This is the Spa Feng Shui product including the 2 optional pedestals which the unit can sit on top of.
  • Manufacturer
    Sybaritic, Inc
  • 1 Event

제조사

Sybaritic, Inc
  • 제조사 주소
    Sybaritic, Inc, 9220 James Ave S, Bloomington MN 55431-2302
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

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Device Recall Hydrospa Capsules
  • 모델명 / 제조번호(시리얼번호)
    PART E30006 SERIAL NUMBERS: G1070442568, G1070452567, G1060942061, G1061252308, G106064921, G106065928, G10606891, G1061142252, G1061152287, G1061152288, G1061242302, G1070352519, G1061142238, G1061142247, G1061142270, G1061152265, G1061252301, G1061252306, G1070342543, G1060942112, G1061142292, G1061152267, G1070142402, G1070242450, G1070252451, G1070342515, G1070342524, G1070342527, G1070352537, G1070342554, G1070352562, G1070442582, G1070452591, G106075989, G1061042162, G1061042189, G1061052180, G1061052183, G1061052185, G1061052193, G1070542653, G106125312, G1060852039, G1061142239, G1061152237, G1061152251, G1070342508, G1070342511, G1070352514, G1070352555, G1070452580, G1070452586, G1040452600, G106034717, G106054836, G106055876, G106055877, G106055881, G106065924, G106074984, G106074990, G106075988, G106075992, G1060842008, G1060842010, G1060842015, G1060842041, G1060852012, G1060852051, G1060942072, G1060942111, G1060942116, G1060952064, G1060952065, G1060952087, G1060952117, G1060952122, G1061042134, G1061042179, G1061042184, G1061042187, G1061042191, G1061042208, G1061052132, G1061052133, G1061052138, G1061052142, G1061052143, G1061052147, G1061052154, G1061052163, G1061052188, G1061052194, G1061052207, G1061052215, G1061142218, G1061142246, G1061142262, G1061142264, G1061142276, G1061152222, G1061152233, G1061152241, G1061152242, G1061152253, G1061152254, G1061152256, G1061152272, G1061152274, G1061152297, G1061152298, G1061242300, G1061242305, G1061242314, G1061242315, G1061252319, G1061252320, G1070142374, G1070142375, G1070142377, G1070142397, G1070142403, G1070142410, G1070142413, G1070142415, G1070142419, G1070142427, G1070152360, G1070152361, G1070152368, G1070152388, G1070152418, G1070152420, G1070152424, G1070152425, G1070152426, G1070152428, G1070242452, G1070242470, G1070242480, G1070252443, G1070252449, G1070252453, G1070252478, G1070252479, G1070252485, G1070342494, G1070342499, G1070342510, G1070342531, G1070342535, G1070342539, G1070342541, G1070342559, G1070342561, G1070352489, G1070352496, G1070352497, G1070352500, G1070352504, G1070352530, G1070352538, G1070352546, G1070352560, G1070442565, G1070442569, G1070442597, G1070452563, G1070452564, G1070452566, G1070452579, G1070452583, G1070452594, G1070542654, G1060952107, G1070142398, G1070152401, G1070552671, G1070552684, G106074991, G1061042181, G1061042198, G1061052209, G1061052210, G1061052216, G1061142217, G1061142226, G1061142231, G1061142243, G1061142245, G1061152221, G1061152229, G1061152230, G1061152234, G1070142423, G1070242475, G1070342503, G1070342525, G1070352507, G1070352520, G1070352522, G1070352523, G1070352526, G1070352534, G106044763, G106045769, G106054827, G106054844, G106054848, G106054878, G106055834, G106055840, G106055841, G106055881, G106054875, G106054896, G106055893, G106055894, G106054882, G106064923, G106064927, G106065933, G406055869 and G106054870; and  PART E30006-01 SERIAL NUMBERS:  G1060852047, G1061142255, G1061152260, G1061152261, G1061152271, G1061152275, G1060852059, G1060842045, G1060852034, G1061242321, G1061252313, G106852043 and G1060852009.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US including states of CA, IA, MN, NE, NJ, NY, TX and WA and countries of Macedonia, Hungary, Greece, South Africa, Italy, Hong Kong, United Arab Emirates, Greece, Croatia, Australia, Kuwait, Turkey, Mexico, Belgium, England, Barbados, France, Japan, Lebanon, Moldova, Poland, Portugal, Romania, Russia, Spain and Thailand.
  • 제품 설명
    DERMALIFE Spa Jet 2G System. Part #E30006-01 - Spa Jet 2G; Assay w/Pedestal. This is the Spa Jet product including the 2 optional pedestals which the unit can sit on top of. || Part #E30006 - Spa Jet 2G; 220V,50/60Hz. 15A. This is the Spa Jet product without the 2 optional pedestals which the unit can sit on top of.
  • Manufacturer
    Sybaritic, Inc
Device Recall Hydrospa Capsules
  • 모델명 / 제조번호(시리얼번호)
    Part E30008 SERIAL NUMBERS:  G4061142236, G4060942128, G4061052135, G4061042136, G4070142436, G4070452585, G4070252464, G4061242317, G406124307, G406124311, G4061142281, G4070242474, G4070242486, G4070342498, G4070352528, G4061142257, G4061152258, G4061152273, G4070152376, G4070252458, G407044578, G4070342548, G4060842048, G4060852049, G4061152294, G4061252303, G4061252310, G4070242461, G4060952067, G40701424121, G4070152381, G4070152387, G4070342521, G4070352544, G4070552656, G4070552644, G406055898, G4060942068, G4061042145, G4061042214, G4061052149, G4061142244, G4061242326, G4061142299, G4070342506, G4070442577, G4060852053, G4060942074, G4061142259, G4061152228, G4061152240, G4061155248, G4070142363, G4070152400, G4070152408, G4070152437, G4070252463, G4070252473, G4070342517, G4070352495, G4070342529, G4060852019, G4061042186, G4061052212, G4061142224, G4061152220, G4070242448, G4070252442, G4070252484, G4070252487, G4070342491, G4070352505, G4070352509 and G4070352516; and  Part E30008-01 SERIAL NUMBERS:  G406052055, G4061252322, G4060852052, G4070142352, G4061052190, G4061042206, G4061242342, G4061042156, G4061052173, G4061052201, G4061252318, G4060852056 and G4060842058.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US including states of CA, IA, MN, NE, NJ, NY, TX and WA and countries of Macedonia, Hungary, Greece, South Africa, Italy, Hong Kong, United Arab Emirates, Greece, Croatia, Australia, Kuwait, Turkey, Mexico, Belgium, England, Barbados, France, Japan, Lebanon, Moldova, Poland, Portugal, Romania, Russia, Spain and Thailand.
  • 제품 설명
    DERMALIFE Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. || Part #E30008 - Spa-Oceana 2G;220V,50/60HZ-15A. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. that is slightly different than the kit of products included in Part #E30008-01 above.
  • Manufacturer
    Sybaritic, Inc
Device Recall Hydrospa Capsules
  • 모델명 / 제조번호(시리얼번호)
    PART E30006-02 SERIAL NUMBERS:  G1061142263, G1061142291, G1061242316, G1061252324, G1070142367, G1061142263, G1061142291, G1061242316, G1061252324 and G1070142367.
  • 의료기기 분류등급
    Physical Medicine Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- US including states of CA, IA, MN, NE, NJ, NY, TX and WA and countries of Macedonia, Hungary, Greece, South Africa, Italy, Hong Kong, United Arab Emirates, Greece, Croatia, Australia, Kuwait, Turkey, Mexico, Belgium, England, Barbados, France, Japan, Lebanon, Moldova, Poland, Portugal, Romania, Russia, Spain and Thailand.
  • 제품 설명
    DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. || This is the Spa Jet product re-named for Takara Belmont, our New Jersey based distributor, identical to Part #E30006-01 other than the stickers on the unit.
  • Manufacturer
    Sybaritic, Inc