ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)

FDA UDI

Class II (US FDA UDI)

by REMED Co., Ltd.

Identity

Trade Name: ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System) FDA UDI
Generic Name: Magnetic neural stimulation system FDA UDI
Device Name: ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_SW Protocol Change ver FDA UDI
Model / Reference: C-01 FDA UDI
Description: ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_SW Protocol Change ver FDA UDI

Identifiers

Primary DI / UDI-DI: 08809308380546 FDA UDI
510(k) Number: K220625 FDA UDI
FDA Product Code: OBP FDA UDI
GMDN Term: Magnetic neural stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5805 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Magnetic neural stimulation system

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System) by REMED Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K220625 also covers:

ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System) — REMED Co., Ltd.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: REMED Co., Ltd.

Sources (1)

FDA UDI ce74c0f2-a798-4069-8112-0e218d4c8914 35 fields · synced May 31, 2026