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Apolomed

FDA UDI

Class II (US FDA UDI)

by Shanghai Apolo Medical Technology Co., Ltd

Identity

Trade Name
Apolomed FDA UDI
Generic Name
Deep-tissue electromagnetic stimulation system, professional FDA UDI
Device Name
Electromagnetic Stimulation Systems FDA UDI
Model / Reference
HS-591 FDA UDI
Description
Electromagnetic Stimulation Systems FDA UDI

Identifiers

Primary DI / UDI-DI
06970745915911 FDA UDI
510(k) Number
K232409 FDA UDI
FDA Product Code
NGX FDA UDI
GMDN Term
Deep-tissue electromagnetic stimulation system, professional FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Deep-tissue electromagnetic stimulation system, professional

Apolomed by Shanghai Apolo Medical Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Deep-tissue electromagnetic stimulation system, professional.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shanghai Apolo Medical Technology Co., Ltd

Sources (1)

  • FDA UDI 451e063e-0c43-4201-b92e-5e10fa52f6f4 35 fields · synced May 29, 2026