FDA.reportPublic FDA data

iReliev

Primary DI
00853635002433
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
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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 electrodeA non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079213529
Device count
1
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853635002426iRelievET-5050ET-50502018-01-12
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
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
03770018808086actiTENSSUBLIMEDNYN2026-05-27
03770018808093actiTENSSUBLIMEDNYN2026-05-27
03770018808109actiTENSSUBLIMEDNYN2026-05-27
03770018808116actiTENSSUBLIMEDNYN2026-05-27
03770018808253actiTENS MiniSUBLIMEDNYN2026-05-27
03770018808260actiTENS MiniSUBLIMEDNYN2026-05-27
06977159460037GYMMAXGymmax Technology (Shenzhen) Co., Ltd.NYN2026-04-24
06976287180336Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
06976287180343Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
06976287180350Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
04719872263029Well-LifeWELL-LIFE HEALTHCARE LTD.NYN2026-03-30
04719872264132Well-LifeWELL-LIFE HEALTHCARE LTD.NYN2026-03-30
06971712720125ProcomfortHong Qiangxing (Shen Zhen) Electronics LimitedNYN2025-12-10
00810140062697RENPHOJoicom CorporationNYN2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NYN2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NYN2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NYN2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NYN2025-09-11
00810113683379DualPulse CompactManamed, Inc.NYN2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.NYN2025-09-11
06971712720057NEOCARBONHong Qiangxing (Shen Zhen) Electronics LimitedNYN2025-08-31
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NYN2025-08-21
03770018808239actiTENSSUBLIMEDNYN2025-02-07
00092237626870TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
00092237626856TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
00092237626863TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
06924607702959Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17
06924607702966Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17
06924607702973Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17
06924607702980Transcutaneous Electrical Nerve Stimulator For Pain Relief Shenzhen Kentro Medical Electronics Co.,LtdNYN2024-12-17