FDA.reportPublic FDA data

Sport-Z

Primary DI
B872SPZ2000
Brand
Sport-Z
Company
PRIZM MEDICAL, INC.
Model
SPZ200
Published
2020-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K033122000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K0331220005000Z SYSTEM (OTC)Prizm Medical, Inc.2004-08-25NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B872SPZ2000PrimaryHIBCC0
D20008U4Unit of UseHIBCC0

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
790271118
Device count
100
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B872MZ2KIT20Micro-Z IIMZ2KIT22020-05-12
B872MZM1000Micro-Z Mini MZM1002020-05-07
B872MZS2KIT20Micro-Z IIMZ2KIT22020-05-07
B872ITBK440Intelligent Textile Stim-Support Back WrapITBK442024-06-07
B872SSELBW0Stim-Support Elbow BraceSSELBW2024-06-07
B872SSKNEE0Stim-Support Knee BraceSSKNEE2024-06-07
B872SSNECK0Stim-Support Neck BraceSSNECK2024-06-07
B872SSSHLD0Stim-Support Shoulder BraceSSSHLD2024-06-07
B872EMG20130Electro-Mesh GloveEMG20132024-06-06
B872EMSP240Electro-Mesh PanelEMSP242024-06-06
B872EMSP440Electro-Mesh PanelEMSP442024-06-06
B872EMSP480Electro-Mesh PanelEMSP482024-06-06
B872STS33130Silver-Thera SockSTS33132024-06-06
B872STS33140Silver-Thera SockSTS33142024-06-06
B872STS33150Silver-Thera SockSTS33152024-06-06
B872SSS23050Stim-Support Shoulder - XLSSS 23052020-05-11
B872REVSTM20ReviStimREVSTM22020-05-07
D20007Micro-Z IIMZ2KIT22020-05-12
B872EMG20140Electro-Mesh GloveEMG20142020-05-11
B872EMG20150Electro-Mesh GloveEMG20152020-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
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
00850080988411AUVONUAN HEALTHCARE LIMITEDNUH2026-05-06
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
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00850080988404AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
00850080988145AUVONUAN HEALTHCARE LIMITEDNUH2026-03-23
00850080988138AUVONUAN HEALTHCARE LIMITEDNUH2026-03-19
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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
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00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11