FDA.reportPublic FDA data

iReliev

Primary DI
00853635002426
Brand
iReliev
Company
EXCELHEALTH, INC.
Model
ET-5050
Catalog number
ET-5050
Device description
iReliev PlayMakar Therapeutic Wearable System
Published
2018-01-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
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
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161453000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161453000WELL LIFE Wireless TENS/EMS Stimulator, Models WR-2605/2605AWell-Life Healthcare Limited2016-12-05NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853635002433PackageGS120In Commercial Distribution
00853635002426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853635002433008536350024338536350024330853635002433
00853635002426008536350024268536350024260853635002426

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
855-423-2582wecare@ireliev.com

Regulatory Flags#

DUNS number
079213529
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853635002440iRelievET-5555ET-55552018-01-12
00853635002457iRelievET-5454ET-54542018-01-12
00853635002464iRelievET-5252ET-52522018-01-12
00853635002747iRelievET-8080ET-80802018-07-20
00853635002037iRelievET-1313ET-13132016-06-27
00853635002051iRelievCM5050-4CM5050-42016-06-27
00853635002112iRelievCM5050CM50502016-06-27
00853635002259iRelievET-7070ET-70702016-06-27
00853635002266iRelievET-1515ET-15152016-06-27
00853635002273iRelievET-7171ET-71712016-06-27
00853635002280iRelievET-7272ET-72722016-06-27
00853635002433iRelievET-5050ET-50502018-01-12
10853635002447iRelievET-5555ET-55552018-01-12
20853635002741iRelievET-8080ET-80802018-07-20
20853635002451iRelievET-5454ET-54542018-01-12
10853635002461iRelievET-5252ET-52522018-01-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810093080854PainPodHi-Dow International IncorporatedNUH2026-10-19
00810093080854PainPodHi-Dow International IncorporatedNGX2026-10-19
06971712720415CriterionHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-15
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNYN2026-10-13
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-10-13
06971712725922DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-10-13
00850080988671AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988671AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850080988688AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNUH2026-10-08
00850080988695AUVONUAN HEALTHCARE LIMITEDNGX2026-10-08
00850092200006PEPPERPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200013PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200020PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200037PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200044PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200051PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200068PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200075PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200082PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200099PepperPEPPER INTERACTIVE INC.NGX2026-10-05
00850092200105PepperPEPPER INTERACTIVE INC.NGX2026-10-05
06978452680160ZoksiShenzhen Jiantuo Electronics Co., LtdNUH2026-09-03
06978452680160ZoksiShenzhen Jiantuo Electronics Co., LtdNGX2026-09-03
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNUH2026-08-26
06978452680153NAShenzhen Jiantuo Electronics Co., LtdNGX2026-08-26
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNUH2026-08-18
06978452680146MedlinketShenzhen Jiantuo Electronics Co., LtdNGX2026-08-18
00850085485076AUVONAnsion Technology (GuangDong) Co. Ltd.NGX2026-08-17