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
NATIONAL BIOLOGICAL CORPORATION
UVB-089P
In Commercial Distribution

  • 00816878020794 ()


  • Ultraviolet phototherapy unit, home-use
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities. Note1: The electrode on the stimulator is used in the waist. Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
LQ-9525B
In Commercial Distribution

  • 06974700021129 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities. Note1: The electrode on the stimulator is used in the waist. Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uLumb-9533A
In Commercial Distribution

  • 06974700021112 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities. Note1: The electrode on the stimulator is used in the waist. Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uLumb-9532A
In Commercial Distribution

  • 06974700021105 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities. Note1: The electrode on the stimulator is used in the waist. Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uLumb-9531A
In Commercial Distribution

  • 06974700021099 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities. Note1: The electrode on the stimulator is used in the waist. Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uLumb-9530A
In Commercial Distribution

  • 06974700021082 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
LQ-9535A
In Commercial Distribution

  • 06974700021075 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uNeck-9529A
In Commercial Distribution

  • 06974700021068 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uNeck-9521A
In Commercial Distribution

  • 06974700021051 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uNeck-9519A
In Commercial Distribution

  • 06974700021044 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uNeck-9518A
In Commercial Distribution

  • 06974700021037 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uNeck-9517B
In Commercial Distribution

  • 06974700021020 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uNeck-9515A
In Commercial Distribution

  • 06974700021013 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities. Heating: To be used for temporary relief of minor aches and pains.
Shenzhen Leqing Medical Instrument Co., LTD
uNeck-9512A
In Commercial Distribution

  • 06974700021006 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
No Description
BOEKEL INDUSTRIES, INC.
301000
In Commercial Distribution

  • 00863626000201 ()


  • Cryopreserved blood/tissue thawing unit
bath, paraffin
GRIMM SCIENTIFIC INDUSTRIES INC
PARATherm
In Commercial Distribution

  • 00861047000329 ()


  • Physical therapy paraffin wax bath
No Description
Elixir M.D. Inc.
LED Light Therapy Device
In Commercial Distribution

  • 00860013019402 ()


  • Blue/red/infrared phototherapy lamp
ShuntCheck Test Pack consisting of a ShuntCheck Thermosensor, an Instant Cold Pack and a skin marker in a clamshell container
NEURODX DEVELOPMENT LLC
TP-1
In Commercial Distribution

  • 00865435000335 ()
  • 10865435000318 ()
TP-1

  • Heater/cooler system tester kit
Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor
NEURODX DEVELOPMENT LLC
DAQ-1
In Commercial Distribution

  • 00865435000328 ()
DAQ-1

  • Heater/cooler system tester kit
ShuntCheck software - Installed on Windows computer; guides user through test procedure, gathers and analyzes thermal data, presents results screen with Flow Confirmed or Flow Not Confirmed plus a time-temperature graph
NEURODX DEVELOPMENT LLC
SCIII SW
In Commercial Distribution

  • 00865435000311 ()
SCIII SW

  • Heater/cooler system tester kit
Red LED light for the treatment of wrinkles
PULSADERM LLC
RB2010
In Commercial Distribution

  • 00864918000374 ()


  • Blue/red/infrared phototherapy lamp
Plasma Thawing System
CYTOTHERM LP
CT-D1
In Commercial Distribution

  • 00861128000354 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-DR
In Commercial Distribution

  • 00861128000347 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-D4
In Commercial Distribution

  • 00861128000330 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-4T.6C
In Commercial Distribution

  • 00861128000323 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-4T
In Commercial Distribution

  • 00861128000316 ()


  • Cryopreserved blood/tissue thawing unit
Plasma Thawing System
CYTOTHERM LP
CT-4S
In Commercial Distribution

  • 00861128000309 ()


  • Cryopreserved blood/tissue thawing unit
No Description
Silhouet-Tone Corporation
411569
In Commercial Distribution

  • 00667259003895 ()


  • Blue/red/infrared phototherapy lamp
LED light for the treatment of wrinkles
PULSADERM LLC
RB2015
In Commercial Distribution

  • 00858830007061 ()


  • Blue/red/infrared phototherapy lamp
No Description
WR MEDICAL ELECTRONICS CO INC
TB7
In Commercial Distribution

  • 00702173123226 ()


  • Physical therapy paraffin wax bath
No Description
WR MEDICAL ELECTRONICS CO INC
TB6
In Commercial Distribution

  • 00702173123202 ()


  • Physical therapy paraffin wax bath
No Description
WR MEDICAL ELECTRONICS CO INC
TB10
In Commercial Distribution

  • 00702173122809 ()


  • Physical therapy paraffin wax bath
No Description
WR MEDICAL ELECTRONICS CO INC
TB9
In Commercial Distribution

  • 00702173122755 ()


  • Physical therapy paraffin wax bath
4 mode full body panel
BIOPHOTAS, INC.
Series 2 DELUX XL C/US
In Commercial Distribution

  • 00850523007938 ()
CXL2-001

  • Blue/red/infrared phototherapy lamp
4 mode full body panel
BIOPHOTAS, INC.
Series 2 DELUX C/US
In Commercial Distribution

  • 00850523007891 ()
CDL2-001

  • Blue/red/infrared phototherapy lamp
2-mode large panel
BIOPHOTAS, INC.
Series 2 SKIN C/US
In Commercial Distribution

  • 00850523007808 ()
CSK2-001

  • Blue/red/infrared phototherapy lamp
5 Mode Light therapy device with capability of 3 Panels connected
BIOPHOTAS, INC.
Series 2 ELITE C/US
In Commercial Distribution

  • 00850523007761 ()
ELS2-002

  • Blue/red/infrared phototherapy lamp
2 mode small panel
BIOPHOTAS, INC.
Series 2 FACE C/US
In Commercial Distribution

  • 00850523007754 ()
CLF2-001

  • Blue/red/infrared phototherapy lamp
2 mode small panel light therapy device
BIOPHOTAS, INC.
Series 2 HOME C/US
In Commercial Distribution

  • 00850523007747 ()
CPM2-001

  • Blue/red/infrared phototherapy lamp
3 mode small panel light therapy device
BIOPHOTAS, INC.
Series 2 RESTORE C/US
In Commercial Distribution

  • 00850523007730 ()
CLR2-001

  • Blue/red/infrared phototherapy lamp
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