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Low Frequency Therapeutic Device

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref 867.28Model HD2, HD4P, EM80, SL-880, SL-880H, SL-884, EM49, EM59, EM89, SEM44, FT-810, FT-810-1, FT-810-2, FT-610, FT-610B, EM50, EM55, SEM47, SEM48, SEM53, PP-909, PP-909K, PP-919, EM10, EP-300, SP-610510(k) K112392

by Hivox Biotek Inc.

Identity

Device Name
Low Frequency Therapeutic Device EUDAMED
Model / Reference
HD2, HD4P, EM80, SL-880, SL-880H, SL-884, EM49, EM59, EM89, SEM44, FT-810, FT-810-1, FT-810-2, FT-610, FT-610B, EM50, EM55, SEM47, SEM48, SEM53, PP-909, PP-909K, PP-919, EM10, EP-300, SP-610 EUDAMED
867.28 EUDAMED

Identifiers

Primary DI / UDI-DI
04066299867287 EUDAMED
Basic UDI-DI
471988081LFTDM7 EUDAMED
Direct Marketing DI
04066299867287 EUDAMED
EMDN Code
Z120622,Z12062801 EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Romania EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

Low Frequency Therapeutic Device by Hivox Biotek Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Hivox Biotek Inc.
EUDAMED SRN
TW-MF-000052507
FDA Applicant
Hivox Biotek, Inc.
Authorised Representative
HIVOX BIOTEK B.V. NL-AR-000050977

Sources (2)

  • EUDAMED 567332b1-3af8-4f0c-8ef2-97e62d36ca05 85 fields · synced Jun 19, 2026
  • FDA 510(k) K112392 1 fields · synced May 18, 2026