FDA.report

SimulCareII

Primary DI
B495SIMULCAREII0
Brand
SimulCareII
Company
XANACARE TECHNOLOGIES
Model
SimulCareII
Device description
The SimluCare II Multifunction Therapeutic Device is intended for the temporary relieve of minor muscle and joint pain, promoting the relaxation of mu
Published
2017-01-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Product Code Classifications

CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B495SIMULCAREII0PrimaryHIBCC0

GMDN Terms

TermDefinition
Transcutaneous electrical stimulation probeA non-sterile, hand-held, pen-like electrical conductor intended to be held against a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation]. It typically has a metallic tip for skin contact, sometimes using a conductive pad. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
556994536
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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06932307410425JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.GZJ2026-03-03
08032625824480GLOBUSDOMINO SRLGZJ2026-02-23
00714905117649Fab StimCOMPASS HEALTH BRANDS CORP.GZJ2026-02-06
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00810178880799ViveVIVE HEALTH LLCGZJ2026-02-05
16971712720139KINGPAVONINIHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-01-30
06971760281357EmeTermWAT Medical Technology Inc.GZJ2026-01-23
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16971760280104EmeTermWAT Medical Technology Inc.GZJ2025-08-22
16971760281125EmeTermWAT Medical Technology Inc.GZJ2025-08-22
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