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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)_18.8min ver FDA UDI
Model / Reference
B-01 FDA UDI
Description
ALTMS Magnetic Stimulation Therapy System (Blossom TMS Therapy System)_18.8min ver FDA UDI

Identifiers

Primary DI / UDI-DI
08809308380539 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

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

No

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

Similar devices

Also classified as Magnetic neural stimulation system.

Cleared under the same submission

K220625 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
REMED Co., Ltd.

Sources (1)

  • FDA UDI 870834e1-7d15-4623-91f0-66700356b3dd 35 fields · synced Jun 8, 2026