Stimulator, Muscle, Powered

Product Code: IPF

Physical Medicine Ultrasonic Medical Devices (Miscellaneous)

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 890.5850


Radiation TypeAcoustic
Radition SafetyNone
Annual ReportsNo

Products Classified as IPF

5135Stimulator, Muscle, PoweredPowered Muscle Stimulator.

Total Product Life Cycle (TPLC) Devices

5135Stimulator, Muscle, PoweredPowered Muscle Stimulator.

FDA Consensus Standards

Stimulator, Muscle, Powered [36837]21 CFR §890.5850 🔎

Pre-market Notifications for IPF

K222201Biological Feedback And Stimulation SystemMedlander Medical Technology Inc.
K221958Flex-MIEMSI, Inc.
K220994Shoulder PacemakerTMNCS Lab Srl
K220738Motive Knee WrapCyMedica Orthopedics, Inc.
K220327Geko W-3Firstkind Limited
K213197MyOnyx SystemThought Technology Ltd.
K213043Levator Elite (Model LE9011)Shenzhen Dongdixin Technology Co., Ltd.
K212832TimeWaver FrequencyTimeWaver Production GmbH
K211094Nerve And Muscle StimulatorShenzhen XFT Medical Limited
K210979PreliviaRehabtronics Inc.
K210938PowerDot PD-01MT2 Muscle StimulatorSmartmissimo Technologies Pte Ltd
K210604Intellihab SystemCyMedica Orthopedics, Inc.
K210269PowerDot PD-01MT2 Muscle StimulatorSmartmissimo Technologies Pte Ltd
K210002STELLA BIOEGZOTech Sp. Z O. O.
K203710Storz Medical MAGNETOLITH Muscle StimulatorStorz Medical AG

Global Unique Device Identification Database

20665973016775Stimulator, muscle, powered
20817325022105Stimulator, Muscle, Powered
20817325021665Stimulator, Muscle, Powered
20817325020729Stimulator, Muscle, Powered
00817325020718Stimulator, Muscle, Powered
20817120020085Stimulator, Muscle, Powered
20817120020078Stimulator, Muscle, Powered
00816864020579Stimulator, muscle, powered
00816864020258Stimulator, muscle, powered
00816864020173Stimulator, muscle, powered
00816864020005Stimulator, muscle, powered
00815962020207Stimulator, muscle, powered
00815962020191Stimulator, muscle, powered
00815962020184Stimulator, muscle, powered
00815962020153Stimulator, muscle, powered

Maude Adverse Events

CHATTANOOGA INTELECT MOBILE COMBO, INT'L STD, 5CM APPLDJO, LLC2020-03-23
ACCELERATED PERFORMANCE RECOVERY (ARP) MACHINEUNK2020-03-03
OMNISTIM ELECTROTHERAPY ELECTRODEACCELERATED CARE PLUS2020-02-28
CHATTANOOGA LEGEND XT 4CH STIM PKG US STDDJO, LLC2020-02-03
CHATTANOOGA VECTRA NEODJO, LLC2019-11-21
CHATTANOOGA VECTRA NEODJO, LLC2019-11-21
CHATTANOOGA VECTRA NEODJO, LLC2019-10-23
OMNISTIM 500 PROACCELERATED CARE PLUS CORP2019-06-18
ACCURELIEF WIRELESS 3-IN-1 PAIN RELIEF DEVICECOMPASS HEALTH BRANDS2019-03-05
REVITIVE MEDICACTEGY HEALTH INC2019-02-22
ZYNEX MEDICALZYNEX MEDICAL INC.2019-02-01
RICHMARCOMPASS RICHMAR2018-12-11
INTELECT MOBILE 2CH STIM INT'L STDDJO, LLC2018-12-06
VECTRA GENISYSCHATTANOOGA / DJO, LLC2018-08-30
X BODYX-BODY INTERNATIONAL2017-07-13
ELECTRONIC MUSCLE STIMULATORMIHA BODYTEC2017-03-30
VECTRA GENYSISDJO, LLC.2016-11-22
VECTRA GENISYS 2 CHCHATTANOOGA GROUP2016-08-18
HOMEDICS THERA-P MINI MASSAGERHOMEDICS2016-05-04
CHATTANOOGADR COMFORT, A DJO, LLC COMPANY2016-03-15
ZYNEXZYNEX MEDICAL2016-01-12
ZYNEXZYNEX MEDICAL, INC.2016-01-08
ZYNEXZYNEX MEDICAL, INC.2016-01-08
ZYNEXZYNEX MEDICAL, INC.2016-01-08
NEUROTECH KNEEHAB XPBIO-MEDICAL RESEARCH LTD.2015-12-09
CHATTANOOGADJO, LLC2015-11-09
CHATTANOOGADJO, LLC2015-09-30
CONTINUUMEMPI, INC2015-07-28
ZYNEXZYNEX MEDICAL, INC.2015-03-18
ZYNEXZYNEX MEDICAL, INC.2015-03-13
ZYNEXZYNEX MEDICAL, INC.2015-03-13
ZYNEXZYNEX MEDICAL, INC.2015-03-13
ZYNEXZYNEX MEDICAL INC2015-02-11
ZYNEXZYNEX MEDICAL INC2015-02-11
ZYNEXZYNEX MEDICAL INC2015-02-11
ZYNEXZYNEX MEDICAL, INC.2014-12-03
PENA MUSCLE STIMULATOR PROBEINTEGRA NEUROSCIENCES IMPLANTS S.A.2014-10-21
ZYNEXZYNEX MEDICAL2014-08-05
ZYNEXZYNEX MEDICAL2014-08-05
ZYNEXZYNEX MEDICAL2014-08-05
ZYNEXZYNEX MEDICAL2014-08-05
ZYNEXZYNEX MEDICAL2014-08-05
ZYNEXZYNEX MEDICAL, INC.2014-08-05
INTELECTDJO, LLC2014-05-12
INTELECTDJO, LLC2014-04-04
PENA MUSCLE STIMULATOR PROBE (NOT STERILE)INTEGRA NEUROSCIENCES IMPLANTS S.A.2014-02-24
PENA MUSCLE STIMULATOR PROBE (NOT STERILE)INTEGRA NEUROSCIENCES IMPLANTS S.A.2014-02-24
PENA MUSCLE STIMULATOR PROBE (NOT STERILE)INTEGRA NEUROSCIENCES IMPLANTS S.A.2014-02-24
PENA MUSCLE STIMULATOR PROBE (NOT STERILE)INTEGRA NEUROSCIENCES IMPLANTS S.A.2014-02-24
PENA MUSCLE STIMULATOR PROBE (NOT STERILE)INTEGRA NEUROSCIENCES IMPLANTS S.A.2014-02-24
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