ManaMed Transducer Fixation Strap

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,…

Registry build 21.09.26

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 fixation strap has a hook and loop closure that holds the transducer where treatment is desired.

4manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code

Who Else Makes It

All of them in Guangdong. 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IMI
Manufacturer City Province Registered as Device types
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Grandway Technology (Shenzhen) Limited Shenzhen Guangdong Contract manufacturer 6
JKH Health Co., Ltd. Dongguan Guangdong Contract manufacturer 22
Shenzhen Dongdixin Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 18

Record

Regulatory record for ManaMed Transducer Fixation Strap
Listed by Manamed LLC, United States
FDA product code IMI
Device type Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
Device class Class 2
Regulation 21 CFR 890.5300
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2025-09-11

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for ManaMed Transducer Fixation Strap
Catalogue number Size Status
MTFIXSTRAP In distribution
MTWTSTRAP In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Chattanooga DJO, LLC 26
Dynatron Soundhead ` Dynatronics Corp. 6
Ultrasound Accessories Drive DeVilbiss Healthcare 4
Ibramed Ibramed Industria Brasileira de Equipamentos Medicos Eir 4
Solaris Soundhead Dynatronics Corp. 3
50 Plus Soundhead Dynatronics Corp. 3
Therasound EVO Drive DeVilbiss Healthcare 3
Therasound Drive DeVilbiss Healthcare 2
Echo Ultrasound Device (USA) Thermotek, Inc. 2
Therasound Evo 120V Drive DeVilbiss Healthcare 2
Echo Ultrasound Device (PRC) Thermotek, Inc. 2
Therasound EVO Package Drive DeVilbiss Healthcare 2

Showing 12 of 44. All products under Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K222098 2023-03-08
K210284 2022-04-26

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer