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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Bacteria filter heater
VADI MEDICAL TECHNOLOGY CO., LTD.
VH-210
In Commercial Distribution

  • 14719875347020 ()
  • 04719875347023 ()

  • AC 100-120V
800-21101-UL

  • Bottle warmer
The Expiratory Filter Heater is designed to warm the surface of a filter used in the expiratory pathway of a breathing circuit. The device is intended to prolong filter efficiency by minimizing excessive condensation that can cause expiratory resistance. Adding a heated filtration system to a ventilator can also protect the exhalation system and currounding environment from contamination which prevents the spread of infectious diseases. The heater consists of an aluminum heating surface that is thermostatically controlled to maintain an ideal temperature.
MEDIC TRADE CO., LTD.
M-OA-FH01
In Commercial Distribution

  • 04719875322082 ()
  • 14719875322089 ()
  • 24719875322086 ()


  • Breathing circuit condenser
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
Infrared Heated Wrist Wrap
MATSUM INC
KB171210
In Commercial Distribution

  • 00876594009718 ()


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

  • 00876594009695 ()


  • External electric-heating core temperature regulation system pad
Infrared Heated Back Wrap (S/M)
MATSUM INC
KB171290 S/M
In Commercial Distribution

  • 00876594009671 ()


  • External electric-heating core temperature regulation system pad
Infrared Heated Knee Wrap (S/M)
MATSUM INC
KB171280 S/M
In Commercial Distribution

  • 00876594009657 ()


  • External electric-heating core temperature regulation system pad
Infrared Heated Neck and Shoulder Wrap (S/M)
MATSUM INC
KB171250 S/M
In Commercial Distribution

  • 00876594009633 ()


  • External electric-heating core temperature regulation system pad
Infrared Heated Shoulder Wrap (L/XL)
MATSUM INC
KB171240 L/XL
In Commercial Distribution

  • 00876594009619 ()


  • External electric-heating core temperature regulation system pad
Infrared Heated Ankle Wrap
MATSUM INC
KB171230
In Commercial Distribution

  • 00876594000098 ()


  • External electric-heating core temperature regulation system pad
Infrared Heated Back Wrap (XXL/XXXL)
MATSUM INC
KB171290 XXL/XXXL
In Commercial Distribution

  • 00876594000043 ()


  • External electric-heating core temperature regulation system pad
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
The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL 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 XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
AVACEN HOME XL 5-YEAR
In Commercial Distribution

  • 00862800000396 ()


  • Electric pad localized-body heating system
The POP-ON/POP-OFF cuff is for replacement part on Gen 3 AVACEN products (HOME XL and PRO+).
AVACEN MEDICAL, INC
POP-ON/POP-OFF CUFF
In Commercial Distribution

  • 00862800000389 ()


  • Electric pad localized-body heating system
The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL 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 XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
AVACEN HOME XL 3-YEAR
In Commercial Distribution

  • 00862800000372 ()


  • Electric pad localized-body heating system
The AVACEN HOME XL consists of a control panel, temperature controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN HOME XL 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 XL for approximately 10 to 60 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
HOME XL
In Commercial Distribution

  • 00862800000365 ()


  • 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

  • 00862800000358 ()


  • 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 to 30 minutes per treatment session. A vacuum pump creates a slight vacuum (25 to 35mm Hg) on the hand, which accelerates the transfer of heat.
AVACEN MEDICAL, INC
AVACEN HOME+ 5-YEAR
In Commercial Distribution

  • 00862800000341 ()


  • Electric pad localized-body heating system
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
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
Infrared Heated Elbow Wrap (L/XL)
MATSUM INC
KB171260 L/XL
In Commercial Distribution

  • 00876594009701 ()


  • External electric-heating core temperature regulation system pad
Infrared Heated Back Wrap (L/XL)
MATSUM INC
KB171290 L/XL
In Commercial Distribution

  • 00876594009688 ()


  • External electric-heating core temperature regulation system pad
Infrared Heated Knee Wrap (L/XL)
MATSUM INC
KB171280 L/XL
In Commercial Distribution

  • 00876594009664 ()


  • External electric-heating core temperature regulation system pad
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