ManaMed Transducer Fixation Strap

Basic Information

• Brand Name: ManaMed Transducer Fixation Strap
• Primary DI: 00810113682754
• Version / Model: MTWTSTRAP
• Catalog Number: MTWTSTRAP
• Company Name: Manamed, Inc.
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-11
• Public Version: 1
• Public Version Date: 2025-09-19
• Public Version Status: New
• Public Device Record Key: 2d072ba2-0510-43f6-b791-3a163688a1ae

Device Description

The ManaSport+ provides non-invasive therapy of low-intensity pulsed ultrasound for the treatment of selected sub-chronic and chronic medical conditions such as soft tissue injuries, shortened tendons due to past injuries and scar tissues, relief of pain, muscle spasms and joint contractures. ManaSport+ transmits a low-intensity ultrasound signal to the patient’s treatment site through ultrasound gel. The patient will experience little or no sensation while in ultrasound mode. The weighted strap holds the transducer where treatment is desired.

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	890.5300	2
PFW	Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat	Physical Medicine	890.5300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35709	Electrode/transducer strap, reusable	A strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113682754	GS1

Customer Contacts

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