Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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25-pack Mitts
AVACEN MEDICAL, INC
25-pack Mitts
In Commercial Distribution

  • 00862800000334 ()


  • Electric pad localized-body heating system
100-pack Mitts
AVACEN MEDICAL, INC
100-pack Mitts
In Commercial Distribution

  • 00862800000327 ()


  • Electric pad localized-body heating system
Vacuum Chamber Insert (VCI)
AVACEN MEDICAL, INC
VCI
In Commercial Distribution

  • 00862800000310 ()


  • Electric pad localized-body heating system
The AVACEN HOME consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN HOME for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
AVACEN HOME
In Commercial Distribution

  • 00862800000303 ()


  • Electric pad localized-body heating system
Eyelid heat therapy system applicator
Sight Sciences, Inc.
FG 06113
Not in Commercial Distribution

  • 00858027006280 ()
  • 10858027006287 ()
5-105

  • Eyelid heat therapy system applicator
TearCare System Kit including the SmartHub Controller, Charging Cradle, IFU, and Charger Adapter
Sight Sciences, Inc.
FG 06041
Not in Commercial Distribution

  • 00858027006273 ()
5-100

  • Eyelid heat therapy system control unit
TearCare System Kit including the Controller, Charging Cradle, IFU, and Charger Adapter
Sight Sciences, Inc.
FG 05509
Not in Commercial Distribution

  • 00858027006242 ()
5-100

  • Eyelid heat therapy system control unit
Eyelid heat therapy system applicator
Sight Sciences, Inc.
FG 05118
Not in Commercial Distribution

  • 00858027006228 ()
  • 10858027006225 ()


  • Eyelid heat therapy system applicator
Eyelid heat therapy system control unit
Sight Sciences, Inc.
FG 05031
Not in Commercial Distribution

  • 00858027006211 ()


  • Eyelid heat therapy system control unit
No Description
ANODYNE THERAPY, L.L.C.
Rally Back
In Commercial Distribution

  • 00859101006066 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
ANODYNE THERAPY, L.L.C.
300
In Commercial Distribution

  • 00859101006059 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Input DC 5V, 1A, Power 5W. CALMING HEAT Copper Charcoal Neck Wrap N&I 3 Heat ,3 Vibration, This device complies with part 15 of FCC rules.
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
CHNSCC3-3
Not in Commercial Distribution

  • 06936189900869 ()
CWT82004

  • Electric pad localized-body heating system
Input DC 5V, 1A, Power 5W. CALMING HEAT DELUXE MASSAGING NECK WRAP 3 Heat ,9 Vibration, This device complies with part 15 of FCC rules
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
CHNS3-9
In Commercial Distribution

  • 06936189900791 ()
31909-31918

  • Electric pad localized-body heating system
Input DC 5V, 1A, Power 5W. CALMING HEAT MASSAGING NECK WRAP 3 Heat ,3 Vibration, This device complies with part 15 of FCC rules.
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
CHNS3-3
In Commercial Distribution

  • 06936189900784 ()
CWT68104-31908-31917

  • Electric pad localized-body heating system
Input DC 12V, 2A, Power 24W. CALMING HEAT DELUXE MASSAGING SHOULDER WRAP 3 Heat ,9 Vibration, This device complies with part 15 of FCC rules.
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
CHS3-9
In Commercial Distribution

  • 06936189900777 ()
31841

  • Electric pad localized-body heating system
Input DC 12V, 2A, Power 24W. CALMING HEAT MASSAGING SHOULDER WRAP 3 Heat ,3 Vibration, This device complies with part 15 of FCC rules.
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
CHS3-3
In Commercial Distribution

  • 06936189900760 ()
CWT55003-31840

  • Electric pad localized-body heating system
Calming Heat Back Wrap.Input DC 5V, 2A, Power 10W. Calming Heat Back Wrap(3settings). 3 Heat,9 Vibration,3 Lumbar. This device complies with part 15 of FCC rules.
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
CHBWON-9
In Commercial Distribution

  • 06936189900722 ()
31801-31782

  • Electric pad localized-body heating system
Calming Heat Back Wrap.Input DC 5V, 2A, Power 10W. Calming Heat Back Wrap(3settings). 3 Heat,3 Vibration,3 Lumbar. This device complies with part 15 of FCC rules
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
CHBWON-3
In Commercial Distribution

  • 06936189900715 ()
CWT41003-31800-31781

  • Electric pad localized-body heating system
Calming Heat Back Wrap.Input DC 5V, 2A, Power 10W. Calming Heat Back Wrap(3settings). 3 Heat,3 Vibration,3 Lumbar. This device complies with part 15 of FCC rules.
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
CHBWO-3
In Commercial Distribution

  • 06936189900708 ()
CWT41003

  • Electric pad localized-body heating system
Calming heat Deluxe massaging Flexi Wrap. Input DC 5V, 1A, Power 5W. Heat 3 gears ,Shake 9 gears . This device complies with part 15 of FCC rules.
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
25in CHFWU-9
In Commercial Distribution

  • 06936189900685 ()
CWT24003

  • Hand-held electric massager
Calming heat massaging Flexi Wrap. Input DC 5V, 1A, Power 5W. Heat 3 gears ,Shake 3 gears . This device complies with part 15 of FCC rules.
GUANGDONG OKAY TECHNOLOGY CO.,LTD.
25in CHFWU-3
In Commercial Distribution

  • 06936189900678 ()
CWT31003

  • Hand-held electric massager
Meijer Deluxe Shoulder, Neck, and Back Heating Pad Wrap
MEIJER, INC.
74-610
In Commercial Distribution

  • 10708820042541 ()
  • 30708820042545 ()
  • 00708820042544 ()
74-610

  • Electric pad localized-body heating system
No Description
HSIN TEN HEALTH & WEALTH INDUSTRY(HEFEI)Co., Ltd.
YS-70
In Commercial Distribution

  • 06931294730073 ()


  • Freestanding electric massager
No Description
HSIN TEN HEALTH & WEALTH INDUSTRY(HEFEI)Co., Ltd.
HH-1D
In Commercial Distribution

  • 06931294730066 ()


  • Freestanding electric massager
No Description
HSIN TEN HEALTH & WEALTH INDUSTRY(HEFEI)Co., Ltd.
HM-518D
In Commercial Distribution

  • 06931294730028 ()


  • External electric-heating core temperature regulation system pad
No Description
HSIN TEN HEALTH & WEALTH INDUSTRY(HEFEI)Co., Ltd.
HM-518
In Commercial Distribution

  • 06931294730011 ()


  • External electric-heating core temperature regulation system pad
Meijer 12" x 24" Deluxe XL Heating Pad, GRAY
MEIJER, INC.
74-510
In Commercial Distribution

  • 10719283501315 ()
  • 00719283501318 ()
466928

  • Electric pad localized-body heating system
Meijer 12" x 15" Deluxe Heating Pad with LCD Controller
MEIJER, INC.
74-311
In Commercial Distribution

  • 00719283498236 ()
  • 10719283498233 ()


  • Electric pad localized-body heating system
No Description
EASY HEALTHCARE CORPORATION
ETP018
In Commercial Distribution

  • 10855944007663 ()
  • 00855944007666 ()
  • 90855944007669 ()


  • Electric pad localized-body heating system
Blue 3 Bottle Warmer (220V)
COMPASS HEALTH BRANDS CORP.
203-762
In Commercial Distribution

  • 00853904006131 ()


  • Gel warmer
White 3 Bottle Warmer (220V)
COMPASS HEALTH BRANDS CORP.
203-764
In Commercial Distribution

  • 00853904006124 ()


  • Gel warmer
Gray 3 Bottle Warmer (220V)
COMPASS HEALTH BRANDS CORP.
203-763
In Commercial Distribution

  • 00853904006117 ()


  • Gel warmer
Blue 3 Bottle Warmer (120V)
COMPASS HEALTH BRANDS CORP.
201-786
In Commercial Distribution

  • 00853904006100 ()


  • Gel warmer
White 3 Bottle Warmer (120V)
COMPASS HEALTH BRANDS CORP.
201-790
In Commercial Distribution

  • 00853904006094 ()


  • Gel warmer
Gray 3 Bottle Warmer (120V)
COMPASS HEALTH BRANDS CORP.
201-788
In Commercial Distribution

  • 00853904006087 ()


  • Gel warmer
Heating Pad, 12" x 24", Moist/Dry, 4 Position Switch, Auto-Off
COMPLETE MEDICAL SUPPLIES, INC.
BJ185106
In Commercial Distribution

  • 10852321004697 ()
  • 00852321004690 ()


  • Electric pad localized-body heating system
Heating Pad, 12" x 15", Moist/Dry, 4 Position Switch, Auto-Off
COMPLETE MEDICAL SUPPLIES, INC.
BJ185105
In Commercial Distribution

  • 10852321004680 ()
  • 00852321004683 ()


  • Electric pad localized-body heating system
Heating Pad, 12" x 15", Moist/Dry, On/Off Switch
COMPLETE MEDICAL SUPPLIES, INC.
BJ185100
In Commercial Distribution

  • 10852321004673 ()
  • 00852321004676 ()


  • Electric pad localized-body heating system
The Babson Hand Warmer is a powered heating device that provides heat to the palm of the hand to aid in blood collection. It is intended for use by a trained healthcare worker. It is capable of maintaining an elevated device temperature during use of the device.
Babson Diagnostics, Inc.
Babson Hand Warmer
In Commercial Distribution

  • 00850058457000 ()
WI-1-A3280020001

  • Capillary blood collection hand warmer
Eva Thermal (Purple)
Pixie Cup LLC
Eva Thermal (Purple)
In Commercial Distribution

  • 00850068130528 ()


  • Electric pad localized-body heating system
Eva Thermal (Pink)
Pixie Cup LLC
Eva Thermal (Pink)
In Commercial Distribution

  • 00850068130511 ()


  • Electric pad localized-body heating system
No Description
RICHWAY & FUJI BIO INC.
7000MX
In Commercial Distribution

  • 00860163001555 ()


  • Electric pad localized-body heating system
No Description
RICHWAY & FUJI BIO INC.
7000MX
In Commercial Distribution

  • 00860163001548 ()


  • Electric pad localized-body heating system
No Description
RICHWAY & FUJI BIO INC.
7000MX
In Commercial Distribution

  • 00860163001531 ()


  • Electric pad localized-body heating system
No Description
RICHWAY & FUJI BIO INC.
7000MX
In Commercial Distribution

  • 00860163001524 ()


  • Electric pad localized-body heating system
No Description
RICHWAY & FUJI BIO INC.
7000MX
In Commercial Distribution

  • 00860163001517 ()


  • Electric pad localized-body heating system
No Description
RICHWAY & FUJI BIO INC.
7000MX
In Commercial Distribution

  • 00860163001500 ()


  • Electric pad localized-body heating system
Powered heating pad. An assembly of mains electricity (AC-powered) devices designed for the transcutaneous application of heat to a localized body site (e.g., joint, limb) to relieve musculoskeletal pain. It consists of an electric heating pad typically made of synthetic fabric materials, and a hand-held control unit used to regulate and monitor the heat. It is normally available [non-prescription] over-the-counter (OTC) for use in the home.
Hayswell
HP-3000
In Commercial Distribution

  • 00860036001101 ()


  • Electric pad localized-body heating system
Infrared Heated Wrist Wrap
MATSUM INC
KB171210
In Commercial Distribution

  • 00876594009718 ()


  • External electric-heating core temperature regulation system pad
Infrared Heated Elbow Wrap (L/XL)
MATSUM INC
KB171260 L/XL
In Commercial Distribution

  • 00876594009701 ()


  • External electric-heating core temperature regulation system pad
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