FDA.reportPublic FDA data

CVS Health

Primary DI
20050428302969
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
459974
Device description
CVS PRO DG TENS DEV
Published
2019-01-07
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
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171803000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171803000HIVOX OTC Electrical StimulatorHivox Biotek, Inc.2017-11-29NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10050428302962PackageGS14In Commercial Distribution
20050428302969PackageGS18In Commercial Distribution
00050428302965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1005042830296210050428302962
2005042830296920050428302969
00050428302965000504283029650504283029650050428302965

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit 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. 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
1-800-536-0366info@beurer.com

Regulatory Flags#

DUNS number
062312574
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
true
Expiration date on label
true
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
00050428142516CVS0504281425162026-05-28
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
00050428250181CVS Health4969912023-09-01
00050428340769CVS Health 0504283407692026-05-20
00050428490730CVS Health5645702021-04-08
00050428000021CVS Health 0504280000212026-05-19
00050428373927CVS Health 9377672026-04-27
00050428142530CVS0504281425302026-04-23
00050428258590CVS Health8931212020-08-24
00050428265499CVS Health2414832020-02-28
00050428267189CVS Health9356862020-08-24
00050428279472CVS Health9843012020-03-02
00050428290118CVS Health8931262020-08-24
00050428307274CVS Health9356832020-08-24
00050428308615CVS Health5426302019-09-30
00050428311097CVS Health9356852020-08-24
00050428347928CVS Health8931252020-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
00850080988435AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988442AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988459AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988411AUVONUAN HEALTHCARE LIMITEDNUH2026-05-06
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00850080988381AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988398AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988404AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
00850080988145AUVONUAN HEALTHCARE LIMITEDNUH2026-03-23
00850080988138AUVONUAN HEALTHCARE LIMITEDNUH2026-03-19
00850016867209Pixie CupPixie Cup LLCNUH2025-11-05
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128190AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NUH2025-09-11
00810113683379DualPulse CompactManamed, Inc.NUH2025-09-11