FDA.reportPublic FDA data

Somacare

Primary DI
00846362080171
Brand
Somacare
Company
Hi-Dow International Incorporated
Model
JQ-5C-C
Device description
Somacare Digital TENS Unit
Published
2016-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
K102598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102598000HI-DOW-XPHi-Dow International, Inc.2011-05-13NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846362080171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846362080171008463620801718463620801710846362080171

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

Regulatory Flags#

DUNS number
124034476
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
00810093080786PainPod HD-5N-23A2025-12-09
00810093080793PainPod HD-5N-23A2025-12-09
00810093080014PainPodJQ-5C-07A2022-05-16
00851640007573COPPER Fit JQ-5C-07A2020-06-24
00851640007511PainPodJQ-5C-M2020-06-15
00851640007498HiDowJQ-5C-07A 2019-11-21
00851640007504SomacareJQ-5C-C2016-11-02
09351609000023PainPodJQ-5C-B2018-11-02
00851640007009HiDowJQ-5C-E2016-09-01
00851640007016Hi-DowJQ-5C-E2016-09-01
00851640007023HiDowJQ-5C-C2016-09-01
00851640007030HiDowJQ-5C-C2016-09-01
00851640007047HiDowJQ-5C-S2016-09-01
00851640007054HiDowJQ-5C-S2016-09-01
00851640007061HiDowJQ-5C-S2016-09-01
00851640007078HiDowJQ-5C-S2016-09-01
00851640007085HiDowJQ-5C-R2016-09-01
00851640007092HiDowJQ-5C-R2016-09-01
00851640007108HiDowJQ-5C-R2016-09-01
00851640007115HiDowJQ-5C-R2016-09-01

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Primary DI, Brand, Company table
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06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
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
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00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11