FDA.reportPublic FDA data

ManaMed Transducer Holder Patch

Primary DI
00850998008546
Brand
ManaMed Transducer Holder Patch
Company
Manamed, Inc.
Model
MTHPATCH
Catalog number
MTHPATCH
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 fixation strap has a hook and loop closure that holds the transducer where treatment is desired. The transducer holder patch is an adhesive system that attaches the transducer to the skin of the desired treatment area.
Published
2025-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810113682778PrimaryGS10
00850998008546Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113682778008101136827788101136827780810113682778
00850998008546008509980085468509980085460850998008546

GMDN Terms#

Term, Definition table
TermDefinition
Electrode/transducer strap, single-useA 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 single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-508-0712support@manamed.com

Regulatory Flags#

DUNS number
084042331
Device count
30
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810113688473ManaMed IncManaMed Ultrasound Coupling GelMANAGEL012022-12-31
00810113684154ManaEZ Wrist Left, Extra Large EZW3908L-XLEZW3908L-XL2025-10-17
00810113684161ManaEZ Wrist Left, Extra SmallEZW3908L-XSEZW3908L-XS2025-10-17
00810113684178ManaEZ Wrist Right, Extra Large EZW3908R-XLEZW3908R-XL2025-10-17
00810113684185ManaEZ Wrist Right, Extra SmallEZW3908R-XSEZW3908R-XS2025-10-17
00810113682969"ManaEZ Single Panel Knee Immobilizer 18"""EZIMM01-18EZIMM01-182025-11-25
00810113682976"ManaEZ Single Panel Knee Immobilizer 20"""EZIMM01-20EZIMM01-202025-11-25
00810113682983"ManaEZ Single Panel Knee Immobilizer 24"""EZIMM01-24EZIMM01-242025-11-25
00810113682990"ManaEZ 3 Panel Knee Immobilizer 18"""EZ3PIMM01-18EZ3PIMM01-182025-11-25
00810113683003"ManaEZ 3 Panel Knee Immobilizer 20"""EZ3PIMM01-20EZ3PIMM01-202025-11-25
00810113683010"ManaEZ 3 Panel Knee Immobilizer 24"""EZ3PIMM01-24EZ3PIMM01-242025-11-25
00810113683294"ManaEZ 3 Panel Knee Immobilizer 16"""EZ3PIMM01-16EZ3PIMM01-162025-11-25
00810113682600ManaMed IncManaEZ Ice Wrist EZIWST012022-10-13
00850998008119ManaMedManaEZ Wrist Universal RightEZW3908R2022-06-20
00850998008126ManaMedManaEZ Wrist Universal LeftEZW3908L2022-06-20
00810113683065ManaEZ ROM Ice ShortEZR001-XSMEZR001-XSM2025-10-17
00810113683515ManaEZ Hip Ice CureTechEZHIP01B-CTEZHIP01B-CT2025-10-03
00810113683522ManaEZ ROM Ice CureTechEZR001-CTEZR001-CT2025-10-03
00810113683539ManaEZ Shoulder Ice CureTechEZSHLD-CTEZSHLD-CT2025-10-03
00810113683577ManaEZ Ice Long Duration KneeEZLDIP-KNEZLDIP-KN2025-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800016213034PLASONICHironic Co., ltd.IMI2026-03-18
00850033615227Echo Ultrasound Device (PRC) THERMOTEK, INC.IMI2026-02-23
00850033615258Echo Ultrasound Device (PRC)THERMOTEK, INC.IMI2026-02-23
00850033615289Echo Ultrasound Device (USA)THERMOTEK, INC.IMI2026-02-23
00850033615340Echo Ultrasound Device (USA)THERMOTEK, INC.IMI2026-02-23
00850033615371Echo BOX, DRESSING & GEL POD PACK, USND, PRCTHERMOTEK, INC.IMI2026-02-23
00850033615388Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXESTHERMOTEK, INC.IMI2026-02-23
00850033615425Echo Ultra Sound Gel Pods, CartonTHERMOTEK, INC.IMI2026-02-23
00850033615487Echo Ultra Sound Gel Pod, SingleTHERMOTEK, INC.IMI2026-02-23
00850033615500Echo APPLICATOR, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615517Echo POWER SUPPLY, CORD, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615531Echo BELT CLIP, DEVICE PRTCTR, SNGL,USNDTHERMOTEK, INC.IMI2026-02-23
00850033615555Echo ARM STRAP, DEVICE PRTCTR, SNG, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615562Echo GEL, TUBE, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615586echoRx, MANUAL, USER, SINGLE, USNDTHERMOTEK, INC.IMI2026-02-23
00850033615593echoRx, GUIDE,QUICK START,SNGL,USNDTHERMOTEK, INC.IMI2026-02-23
00850033615623Echo CTN, DRESSINGS, USND, USA, QTY 4 BOXESTHERMOTEK, INC.IMI2026-02-23
00850033615630Echo BOX, DRESSING & GEL POD PACK, USND, USATHERMOTEK, INC.IMI2026-02-23
00810113682778ManaMed Transducer Holder PatchManamed, Inc.IMI2025-09-11
00810113682754ManaMed Transducer Fixation StrapManamed, Inc.IMI2025-09-11
00810113682761ManaMed Transducer Fixation StrapManamed, Inc.IMI2025-09-11
08720618311108Sonopuls 190Enraf-Nonius B.V.IMI2025-02-11
08720618311221Sonopuls 190Enraf-Nonius B.V.IMI2025-02-11
00850030915191RichmarSouth Dakota Partners Inc.IMI2023-08-02
00850030915214RichmarSouth Dakota Partners Inc.IMI2023-08-02
00850030915221RichmarSouth Dakota Partners Inc.IMI2023-08-02
07290110122317Accent Prime System 120V For Inc.ALMA LASERS LTD.IMI2022-11-22
07290110122324Accent Prime UltraSpeed Applicator for Inc.ALMA LASERS LTD.IMI2022-11-22
07290110122331Accent Prime MiniSpeed Applicator for Inc.ALMA LASERS LTD.IMI2022-11-22
07290110122348Accent Prime Ultra Applicator for Inc.ALMA LASERS LTD.IMI2022-11-22