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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BDA Attachment XL Cone
LITECURE LLC
PRD-000644-000
In Commercial Distribution

  • 00854103007318 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment Head Large Cone
LITECURE LLC
PRD-000230-000-L
In Commercial Distribution

  • 00854103007288 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment head Large Ball
LITECURE LLC
PRD-000229-000-L
In Commercial Distribution

  • 00854103007271 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment head Small Cone
LITECURE LLC
PRD-000232-000-L
In Commercial Distribution

  • 00854103007264 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Xl Rolling Pin Attachment
LITECURE LLC
PRD-000721-000-L
In Commercial Distribution

  • 00854103007257 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment XL Cone
LITECURE LLC
PRD-000644-000-L
In Commercial Distribution

  • 00854103007240 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment head Flat Window
LITECURE LLC
PRD-000233-000-L
In Commercial Distribution

  • 00854103007233 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment head Small Ball
LITECURE LLC
PRD-000231-000-L
In Commercial Distribution

  • 00854103007226 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment Head Large Cone
LITECURE LLC
PRD-000230-010-L
In Commercial Distribution

  • 00854103007219 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
BDA Attachment head Large Ball
LITECURE LLC
PRD-000229-010-00-L
In Commercial Distribution

  • 00854103007202 ()


  • Musculoskeletal/physical therapy laser beam guide tip, transcutaneous
Mains powered, Infrared phototherapy device emitting up to 15 W at 810 & 980 nm. The LightForce EX (LTS-1500) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation. The EX is a portable medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch, or optional foot switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
LITECURE LLC
LTS-1500
In Commercial Distribution

  • 00854103007028 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Infrared phototherapy device emitting up to 15 W at 980 & 810 nm. The device can be powered through its battery pack or mains power. The LightForce FX (LTC-1500) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting. relaxation of the muscle tissue and to temporarily increase local blood circulation. The FX is a compact, portable, and mobile medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch, or optional foot switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
LITECURE LLC
LTC-1500
In Commercial Distribution

  • 00854103007011 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Mains powered, infrared phototherapy device emitting up to 9 W at 980 nm. The LightForce PRO (LTC-900) is indicated for emitting energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting. relaxation of the muscle tissue and to temporarily increase local blood circulation. The PRO is a compact, portable medical laser therapy system. The laser light delivery system consists of a flexible optical fiber threaded through a lightweight hand piece. Activation occurs when the operator enables the laser and presses the finger switch. Depending on laser system configuration, the finger switch can function as an on/off switch. A touch-screen display panel allows the operator to adjust or set laser output level. The laser can operate in continuous wave mode or controlled pulse mode.
LITECURE LLC
LTC-900
In Commercial Distribution

  • 00854103007004 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The Joovv Go NIR is a rechargeable, battery powered infrared LED heating device for therapeutic pain relief.
JOOVV, INC.
EA-012850000
Not in Commercial Distribution

  • 10855501008225 ()
  • 00855501008228 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The Joovv Solo is a red/infrared LED heating device for therapeutic pain relief.
JOOVV, INC.
EA-150660850
Not in Commercial Distribution

  • 10855501008010 ()
  • 00855501008013 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
The Joovv Mini is a red/infrared LED heating device for therapeutic pain relief.
JOOVV, INC.
EA-060660850
Not in Commercial Distribution

  • 00855501008006 ()
  • 10855501008003 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
Fingertip Pulse Oximeter
Caring Mill
MD300C29
In Commercial Distribution

  • 00854875008209 ()
  • 10854875008206 ()


  • Pulse oximeter, line-powered
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500BL
In Commercial Distribution

  • 00856964007964 ()
M430N-MBBL-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500DL-M Black
In Commercial Distribution

  • 00856964007919 ()
M430N-MABK-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500E White
In Commercial Distribution

  • 00856964007827 ()
M430N-DLWH-CMZA-4

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500E Pink
In Commercial Distribution

  • 00856964007810 ()
M430N-DLPK-CMZA-AX

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500DL Pink
In Commercial Distribution

  • 00856964007803 ()
M430N-AAPK-JPZA-M2

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500E Black
In Commercial Distribution

  • 00856964007780 ()
M430N-DLBK-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500C Black
In Commercial Distribution

  • 00856964007728 ()
M430N-DCBK-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500DL Purple
In Commercial Distribution

  • 00856964007704 ()
M430N-AAVO-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500DL Black
In Commercial Distribution

  • 00856964007698 ()
M430N-AABK-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter (500E)
EINSTEIN ASSOCIATES LLC
500E purple
In Commercial Distribution

  • 00856964007582 ()
M430N-DLVO-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500CL
In Commercial Distribution

  • 00856964007513 ()
M430N-ABCL-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter (500B)
EINSTEIN ASSOCIATES LLC
500B
In Commercial Distribution

  • 00856964007292 ()
M430N-DLBL-LHZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500D Blue
In Commercial Distribution

  • 00856964007100 ()
M430N-DLBL-JPZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500D Black
In Commercial Distribution

  • 00856964007094 ()
M430N-DLBK-JPZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500D Pink
In Commercial Distribution

  • 00856964007087 ()
M430N-DLPK-JPZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500D Purple
In Commercial Distribution

  • 00856964007070 ()
M430N-DLVO-JPZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500DL Purple
In Commercial Distribution

  • 00856964007063 ()
M430N-AAVO-JPZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500DL Pink
In Commercial Distribution

  • 00856964007056 ()
M430N-AAPK-JPZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500DL Black
In Commercial Distribution

  • 00856964007049 ()
M430N-AABK-JPZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500DL Blue
In Commercial Distribution

  • 00856964007032 ()
M430N-AABL-JPZA

  • Pulse oximeter
Fingertip Pulse Oximeter (500BL)
EINSTEIN ASSOCIATES LLC
400B
In Commercial Distribution

  • 00856964007025 ()
M430N-AABL-LHZA

  • Pulse oximeter
Fingertip Pulse Oximeter (500E)
EINSTEIN ASSOCIATES LLC
430/DL
In Commercial Distribution

  • 00856964007018 ()
M430N-DLWH-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter (300A)
EINSTEIN ASSOCIATES LLC
430P
In Commercial Distribution

  • 00856964007001 ()
M430N-PDWH-CMZA

  • Pulse oximeter
No Description
IHEALTH LAB INC.
PO3
In Commercial Distribution

  • 10855111003276 ()
  • 00855111003279 ()
  • 20855111003273 ()


  • Pulse oximeter
No Description
JOICOM CORPORATION
RP-PO001
In Commercial Distribution

  • 30850023727009 ()
  • 00850023727008 ()
OCH

  • Pulse oximeter
Pediatric and Adult Pulse Oximeter
Gpd Health LLC
GPD-PO1GR01C
In Commercial Distribution

  • 00850022983023 ()


  • Pulse oximeter
No Description
LED INTELLECTUAL PROPERTIES LLC
PP-ALS
In Commercial Distribution

  • 00850030819079 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
LED INTELLECTUAL PROPERTIES LLC
LS4P
In Commercial Distribution

  • 00850030819062 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
LED INTELLECTUAL PROPERTIES LLC
PP-PLS / PP-AALS
In Commercial Distribution

  • 00850030819055 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
LED INTELLECTUAL PROPERTIES LLC
LS4W / AALS-Pro
In Commercial Distribution

  • 00850030819048 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
LED INTELLECTUAL PROPERTIES LLC
LS4A / ALS-Pro
In Commercial Distribution

  • 00850030819031 ()


  • Musculoskeletal infrared phototherapy unit, non-wearable
No Description
LED INTELLECTUAL PROPERTIES LLC
LSBED-P-18240
In Commercial Distribution

  • 00850030819017 ()
1-1135

  • Musculoskeletal infrared phototherapy unit, non-wearable
KINEON MOVE+, model: XG-01B, is an over-the-counter light-emitting diode (LED) combined laser-emitting device that emits energy for knee pain relief.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
XG-01B
In Commercial Distribution

  • 05060981240005 ()


  • Red-light phototherapy unit, professional
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