Megapulse III/OmniSWD

GUDID 00858703006085

Shortwave Diathermy for the use of applying therapeutic deep heat

ACCELERATED CARE PLUS CORP

Short-wave diathermy treatment system generator

• Primary Device ID: 00858703006085
• NIH Device Record Key: 20975e55-984d-484c-afda-2f3dbde035ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Megapulse III/OmniSWD
• Version Model Number: 1903030
• Company DUNS: 828331616
• Company Name: ACCELERATED CARE PLUS CORP
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-350-1100
• Email: customersupport@acplus.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858703006085 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153456

FDA Product Code

• IMJ: Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-16

Devices Manufactured by ACCELERATED CARE PLUS CORP

• 00858703006375 - OmniTour: 2023-12-04 Therapy cycling feedback software
• 00858703006313 - OmniFlow Software: 2023-09-14 Respiratory assessment and exercise software
• B179OMNI13E87E4 - OmnisEMG: 2023-09-14 Biomechanical function analysis / interactive rehabilitation system
• 00858703006337 - Synchrony Dysphagia Solutions by ACP: 2023-09-11 Bioelectrical signal analysis software; Biomechanical function analysis, interactive rehabilitation system
• 00858703006351 - OmniVR Elite: 2023-09-11 Virtual display rehabilitation system
• 04041925002799 - OmniCycle Elite: 2023-09-11 Powered exercise therapy bicycle
• 04041925002805 - OmniStand: 2023-09-11 Exerciser, non-measuring for stroke rehabilitation
• 00858703006139 - OmniVersa: 2023-08-25 Combination electrical stimulation/ultrasound for physical therapy