AccessGUDID - DEVICE: Neuroprobe 500 Pro (00858703006054)

GUDID

Device Identifier (DI) Information

Brand Name: Neuroprobe 500 Pro
Version or Model: 140500B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ACCELERATED CARE PLUS CORP

Primary DI Number: 00858703006054
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 828331616 *Terms of Use

Device Description: The Neuroprobe® 500 Pro gives the clinician the option of using any combination of an Estim probe, Interferential Current in bipolar or quadripolar modes, or Monochromatic Infrared Therapy to reduce pain and increase circulation. Flexible neoprene pads deliver heat and Infrared therapy through multiple clusters of infrared and red visible super luminous diodes (SLD). The Neuroprobe® 500 Pro’s optional probe with fully adjustable parameters provides a wide variety of uses for pain management with trigger point stimulation for pain control. The Neuroprobe® 500 Pro provides a nerve block mode through treatment pads with high output capable of sensory nerve block, or through the optional probe to produce local trigger point anesthesia.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61186	Multi-modality physical therapy system, professional-use	An assembly of electrically-powered devices designed for professional use to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, electrotherapy) either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders (e.g., joint pain/inflammation, stiffness, soft tissue injuries, muscle atrophy); it may in addition be used for aesthetic skin/body contouring (e.g., minimize cellulite, loose or wrinkled skin). It consists of a multi-modality control unit/generator, and dedicated applicators for the transcutaneous delivery of energy.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K831147	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aceb953d-1d89-4577-9e57-25e86ed07747
Public Version Date: April 18, 2025
Public Version Number: 5
DI Record Publish Date: August 16, 2016