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Magsculpt

FDA UDI

Class II (US FDA UDI)

by K1MEDGLOBAL Co., Ltd.

Identity

Trade Name
MAGSCULPT FDA UDI
Generic Name
Deep-tissue electromagnetic stimulation system, professional FDA UDI
Model / Reference
MST-1001 FDA UDI

Identifiers

Primary DI / UDI-DI
08809956800151 FDA UDI
510(k) Number
K222400 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

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Deep-tissue electromagnetic stimulation system, professional

Magsculpt by K1MEDGLOBAL 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.

Cleared under the same submission

K222400 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
K1MEDGLOBAL Co., Ltd.

Sources (1)

  • FDA UDI 33b82bc4-f327-4c6b-87b6-450fb3c78dbf 33 fields · synced May 30, 2026