FDA.reportPublic FDA data

DualPulse Compact Replacement Gel Pad

Primary DI
00810113683386
Brand
DualPulse Compact Replacement Gel Pad
Company
Manamed, Inc.
Model
DPC-RP
Catalog number
DPC-RP
Device description
DualPulse Compact NMES device is designed for ease of use by eliminating wires or standalone electrodes. This device is single patient use and is designed for use in the home to treat muscle atrophy due to lack of use or surgery. Powered muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditionsCompletely portable no wires or bulky devicesCan be placed anywhere treatment is desiredBattery operatedReusable - simply replace pads and batteries
Published
2025-09-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810113683386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810113683386008101136833868101136833860810113683386

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
084042331
Device count
1
Lot or batch
true
Manufacturing date on label
true

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
G345SL2000CIONICCionic, Inc.IPF2026-06-04
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
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06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02
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06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
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06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808086actiTENSSUBLIMEDNYN2026-05-27
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDNYN2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDNYN2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27