FDA.reportPublic FDA data

Femmacalm

Primary DI
06971712727445
Brand
Femmacalm
Company
Hong Qiangxing (Shen Zhen) Electronics Limited
Model
TENS
Published
2016-12-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
OTC
true

Product Codes#

Code, Name table
CodeName
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZFStimulator, Peripheral Nerve, Implanted (Pain Relief)Neurology2
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121719000
K233067000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121719000SM TENS & PMSHong Qiangxing (Shenzhen) Electronics Limited2013-05-10NGX
K233067000Wireless TENS & EMS (Model SM9110,SM9113,SM9116)Chongqing Rob Linka Science and Technology Co., Ltd.2024-07-19NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971712727445PrimaryGS10
06971712727438Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971712727445069717127274456971712727445
06971712727438069717127274386971712727438

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

Regulatory Flags#

DUNS number
421286946
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971712725366DOMASSM95552023-06-06
06971712722846DOMASTENS2022-11-15
06971712722860ZQQYSM91162022-11-30
06971712725939SalitySM91872023-09-14
06971712722426MASTOGOSM91872022-09-17
06971712725359DOMASSM90752026-07-09
06971712722693DOMASSM90752026-07-09
06971712727636ONENTECHSM91162026-07-03
06971712722709DOMASTENS2022-10-20
06971712722075MASTOGOSunmas TENS & PMS2026-06-02
06971712726943MASTOGOPain Therapy Device2026-05-30
06971712722990SalitySunmas TENS & PMS2026-05-28
06971712727704YUN MANSIONWireless TENS & EMS2026-05-26
06971712727698BLEASEWireless TENS & EMS2016-12-07
06971712727087Dr. O SolutionsTENS &PMS2026-05-18
06971712727094auraTENS&EMS2024-06-25
06971712726950MASTOGOSunmas TENS & PMS2024-06-03
06971712727988mastogoSunmas TENS & PMS2024-11-20
06971712723621BELIFUSM90552025-08-05
06971712722587CESLIFFSM90552022-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988657AUVONUAN HEALTHCARE LIMITEDNUH2026-07-22
00850080988657AUVONUAN HEALTHCARE LIMITEDNGX2026-07-22
06978146200117SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
06978146200124SinrelSHENZHEN SINREL TECH LTDNUH2026-07-21
00850085485090AUVONAnsion Technology (GuangDong) Co. Ltd.NUH2026-07-16
00860015112446Doctor's Choice®CLINICAL HEALTH SERVICES, INC.NUH2026-07-14
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-07-09
00850080988473AUVONUAN HEALTHCARE LIMITEDNGX2026-06-24
00850080988473AUVONUAN HEALTHCARE LIMITEDNUH2026-06-24
00812537030234Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
00812537032399Therapy DiscNALU MEDICAL, INC.GZF2026-01-19
06971712725939SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2023-09-14
06971712725939SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2023-09-14
06971712725366DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2023-06-06
06971712725366DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2023-06-06
06971712722860ZQQYHong Qiangxing (Shen Zhen) Electronics LimitedNGX2022-11-30
06971712722860ZQQYHong Qiangxing (Shen Zhen) Electronics LimitedNUH2022-11-30
06971712722846DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNGX2022-11-15
06971712722846DOMASHong Qiangxing (Shen Zhen) Electronics LimitedNUH2022-11-15
00812537032917Nalu Medical, Inc.NALU MEDICAL, INC.GZF2022-09-30
00812537034317Nalu Medical, Inc.NALU MEDICAL, INC.GZF2022-09-30
00812537034355Nalu Medical, Inc.NALU MEDICAL, INC.GZF2022-09-30
06971712722426MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2022-09-17
06971712722426MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2022-09-17
00812537030630Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537031910Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10
00812537032986Nalu Medical, Inc.NALU MEDICAL, INC.GZF2021-12-10