FDA.report

SCENAR

Primary DI
04650057290679
Brand
SCENAR
Company
OKB RITM, ZAO
Model
SCENAR-1-NT (version 02C)
Published
2017-05-26
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
04650057290679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04650057290679046500572906794650057290679

GMDN Terms

TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Sterilization Methods

Method

Regulatory Flags

DUNS number
357571053
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04650057290631SCENARSCENAR-1-NT (version 02.1)2020-02-12
04650057290662SCENARSCENAR-1-NT (version 02.1C)2020-02-12
04650057290051SCENARCHANS-01-SCENAR-M2017-05-26
04650057290082SCENARSCENAR-1-NT (version 02)2017-05-26

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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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