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

  • 06931294730011 ()


  • External electric-heating core temperature regulation system pad
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
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
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
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
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
No Description
ANODYNE THERAPY, L.L.C.
300
In Commercial Distribution

  • 00859101006059 ()


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

  • 00859101006066 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Weighted Back wrap Far Infrared heating pad with Negative ion emitted
CHARMING WORLD ENTERPRISE LIMITED
WF220110AC4DCM
In Commercial Distribution

  • 00850055047044 ()


  • Electric pad localized-body heating system
Extreme Large 27x37 inches Weight Far Infrared Heating pad with Negative ion emitted
CHARMING WORLD ENTERPRISE LIMITED
WF370270AC4DCM
In Commercial Distribution

  • 00850055047020 ()


  • Electric pad localized-body heating system
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
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
IAN 366497_2101 Shoulder Heating Pad (Red) SHK 50 Art. No. 211.67/ EAN 4211125211677 Art. No. 277.80/ EAN 4211125277826
BEURER NORTH AMERICA, L.P.
SHK50 (Red)
In Commercial Distribution

  • 10850031772073 ()
  • 00850031772076 ()


  • Electric pad localized-body heating system
IAN 366497_2101 Shoulder Heating Pad (Grey) SHK 50 Art. No. 211.66/ EAN 4211125211653 Art. No. 277.80/ EAN 4211125277802
BEURER NORTH AMERICA, L.P.
SHK50 (Grey)
In Commercial Distribution

  • 10850031772066 ()
  • 00850031772069 ()


  • Electric pad localized-body heating system
IAN 387716_2101 Abdominal and Back Heating Pad (Red) SHK 42 Art. No. 211.64/ EAN 4211125211646 Art. No. 277.83/ EAN 4211125277857
BEURER NORTH AMERICA, L.P.
SHK42 (Red)
In Commercial Distribution

  • 10850031772059 ()
  • 00850031772052 ()


  • Electric pad localized-body heating system
IAN 387716_2101 Abdominal and Back Heating Pad (Grey) SHK 42 Art. No. 211.63/ EAN 4211125211622 Art. No. 277.83/ EAN 4211125277833
BEURER NORTH AMERICA, L.P.
SHK42 (Grey)
In Commercial Distribution

  • 10850031772042 ()
  • 00850031772045 ()


  • Electric pad localized-body heating system
IAN 387714_2101 Back and Neck Heating Pad (Red) SHK 34 Art. No. 211.61/ EAN 4211125211615 Art. No. 277.86/ EAN 4211125277888
BEURER NORTH AMERICA, L.P.
SHK34 (Red)
In Commercial Distribution

  • 10850031772035 ()
  • 00850031772038 ()


  • Electric pad localized-body heating system
IAN 387714_2101 Back and Neck Heating Pad (Grey) SHK 34 Art. No 211.60/ EAN Art. No 277.86/ EAN 4211125277864
BEURER NORTH AMERICA, L.P.
SHK34 (Grey)
In Commercial Distribution

  • 10850031772028 ()
  • 00850031772021 ()


  • Electric pad localized-body heating system
IAN 366501_2101 Heating Pad (Red) SHK 22 Art. No 211.58/ EAN 4211125211585 Art. No 211.68/ EAN 4211125211790
BEURER NORTH AMERICA, L.P.
SHK22 (Red)
In Commercial Distribution

  • 10850031772011 ()
  • 00850031772014 ()


  • Electric pad localized-body heating system
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