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Biofeedback Nerve and Muscle Stimulator

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref KM580Ref KM531Ref MDA 0305Model KM530

by Shenzhen Konmed Technology Co., Ltd.

Identity

Trade Name
Biofeedback nerve and muscle stimulator EUDAMED
KONMED /Pelvifine FDA UDI
Generic Name
Pelvic floor exercise biofeedback device FDA UDI
Device Name
Biofeedback Nerve and Muscle Stimulator EUDAMED
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment. FDA UDI
Model / Reference
KM580 EUDAMED
KM530 EUDAMEDFDA UDI
KM531 EUDAMEDFDA UDI
MDA 0305 EUDAMED
Description
This Biofeedback Nerve and Muscle Stimulator is a new type of biofeedback and neuromuscular electrical stimulation therapy device through the evaluation of myoelectric signal acquisition, multimedia biofeedback training, electromyography triggered electrical stimulation, passive electrical stimulation training and treatment. FDA UDI

Identifiers

Primary DI / UDI-DI
06970935830765 EUDAMED
06970935830536 EUDAMEDFDA UDI
06970935830543 EUDAMEDFDA UDI
Basic UDI-DI
697093583KM580KP EUDAMED
B-06970935830543 EUDAMED
B-06970935830536 EUDAMED
Direct Marketing DI
06970935830765 EUDAMED
510(k) Number
K202648 FDA UDI
FDA Product Code
IPF FDA UDI
KPI FDA UDI
HCC FDA UDI
EMDN Code
Z12062705 MYOELECTRIC CONTROL STIMULATORS EUDAMED
U070399 PELVIC FLOOR REHABILITATION DEVICES - OTHER EUDAMED
GMDN Term
Pelvic floor exercise biofeedback device FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
876.5320 FDA UDI
882.5050 FDA UDI
Market of Registration
Italy EUDAMED
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Biofeedback Nerve and Muscle Stimulator by Shenzhen Konmed Technology Co., Ltd. — Class IIa — MDD, FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Shenzhen Konmed Technology Co., Ltd.
EUDAMED SRN
CN-MF-000018375
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (6)

  • EUDAMED 3344145d-00a0-4ecd-8598-ebe67302889d 61 fields · synced Jul 12, 2026
  • FDA UDI 59c5f98f-1f67-4104-bbdf-400111326782 34 fields · synced May 29, 2026
  • FDA UDI e909fa65-a1dd-4c01-9836-9fd40aa865d7 34 fields · synced May 30, 2026
  • EUDAMED 08261af1-303d-43f7-ad88-3c54a9efdbf7 61 fields · synced Jul 10, 2026
  • EUDAMED 63afbe23-9e43-4c01-88be-aaae60d9f6a5 61 fields · synced Jul 12, 2026
  • FDA 510(k) K220161 1 fields · synced May 18, 2026