Neuroprobe 500 Pro

Basic Information

• Brand Name: Neuroprobe 500 Pro
• Primary DI: 00858703006054
• Version / Model: 140500B
• Company Name: ACCELERATED CARE PLUS CORP
• Labeler DUNS: 828331616
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-16
• Public Version: 4
• Public Version Date: 2021-09-20
• Public Version Status: Update
• Public Device Record Key: aceb953d-1d89-4577-9e57-25e86ed07747

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	882.5890	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61186	Multi-modality physical therapy system	An assembly of electrically-powered devices designed to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, and microcurrent 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, plantar fasciitis); 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00858703006054	GS1
Package	10858703006051	GS1	ship carton	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K831147	000