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EVE Synergy +1 more model

FDA UDI

Class II (US FDA UDI)

by Weero Co., Ltd.

Identity

Trade Name
EVE Synergy; EVE Titan FDA UDI
Generic Name
Multi-modality physical therapy system, professional-use FDA UDI
Device Name
1) EVE Synergy is also marketed under the brand name 'EVE Titan' with an updated logo design. 2) This device provides pain relief through RF (Radio Frequency), EMS (Electrical Muscle Stimulation), and TENS (Transcutaneous Electrical Nerve Stimulation) technologies. It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission. FDA UDI
Model / Reference
EVE-20M FDA UDI
Description
1) EVE Synergy is also marketed under the brand name 'EVE Titan' with an updated logo design. 2) This device provides pain relief through RF (Radio Frequency), EMS (Electrical Muscle Stimulation), and TENS (Transcutaneous Electrical Nerve Stimulation) technologies. It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission. FDA UDI

Identifiers

Primary DI / UDI-DI
08809851470091 FDA UDI
510(k) Number
K241433 FDA UDI
FDA Product Code
IPF FDA UDI
GZJ FDA UDI
GMDN Term
Multi-modality physical therapy system, professional-use FDA UDI
Models / Variants
EVE Synergy FDA UDI
EVE Titan FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
882.5890 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: Multi-modality physical therapy system, professional-use

EVE Synergy +1 more model by Weero Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — 2 models — regulatory data on deviCERTS

Similar devices

Also classified as Multi-modality physical therapy system, professional-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Weero Co., Ltd.

Sources (1)

  • FDA UDI 3e9284c3-2d92-4a2e-b6dc-4914eafb7a64 34 fields · synced May 30, 2026