FDA.reportPublic FDA data

Beurer

Primary DI
00810110200210
Brand
Beurer
Company
BEURER NORTH AMERICA, L.P.
Model
EM29
Catalog number
642.31
Device description
Knee and Elbow TENS Device
Published
2023-10-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K200838000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200838000Tyece OTC TENS ModelTyece Limited2020-08-12NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810110200217PackageGS14In Commercial Distribution
20810110200214PackageGS14In Commercial Distribution
00810110200210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081011020021710810110200217
2081011020021420810110200214
00810110200210008101102002108101102002100810110200210

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.

Contacts#

Phone, Email table
PhoneEmail
1-800-536-0366info@beurer.com

Regulatory Flags#

DUNS number
078497467
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003500164BeurerFM250649.472019-06-28
00850003500041BeurerIL51 Art.- No. 619.732019-03-04
00852547004108BeurerIL50 2016-09-24
00850003500478BeurerOT80792.972021-10-01
00810110200159BeurerBM69101.352023-11-07
10810110200156BeurerBM69101.352023-11-07
00853879007515BeurerPREMIUM 800W101.732023-10-23
10853879007512BeurerPREMIUM 800W101.732023-10-23
00810110200111BeurerAuto 400101.082023-10-20
00810110200128BeurerDeluxe 600101.072023-10-20
00810110200166BeurerPREMIUM 800101.552023-10-20
00850018808705BeurerEM 49662.782023-10-20
00850018808910BeurerBM27651.992023-10-20
10810110200118BeurerAuto 400101.082023-10-20
10810110200125BeurerDeluxe 600101.072023-10-20
10810110200163BeurerPREMIUM 800101.552023-10-20
10810110200217BeurerEM29642.312023-10-20
10850018808702BeurerEM 49662.782023-10-20
10850018808917BeurerBM27651.992023-10-20
00850003500225Vital ControlSEM44 662.702019-04-22

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Primary DI, Brand, Company table
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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
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