← Back to catalogue

Sano

FDA UDI

Class II (US FDA UDI)

by Beijing Sano Lasers S&T Development Co., Ltd.

Identity

Trade Name
SANO FDA UDI
Generic Name
Deep-tissue electromagnetic stimulation system, professional FDA UDI
Device Name
The proposed device is a type of the most advanced electromagnetic,non-invasive treatment machine (with attachments). It is used for muscle tension enhancement and muscle strengthening on abdomen, hips, thighs, arms, etc. Three models (SHE-MSP003, SHE-MSP002 and SHE-MSP001) are included in HI-EMT MAGSHAPE series products, and they have the same intended purposes, working theories and specifications. FDA UDI
Model / Reference
SHE-MSP003 FDA UDI
Description
The proposed device is a type of the most advanced electromagnetic,non-invasive treatment machine (with attachments). It is used for muscle tension enhancement and muscle strengthening on abdomen, hips, thighs, arms, etc. Three models (SHE-MSP003, SHE-MSP002 and SHE-MSP001) are included in HI-EMT MAGSHAPE series products, and they have the same intended purposes, working theories and specifications. FDA UDI

Identifiers

Primary DI / UDI-DI
06973511890092 FDA UDI
510(k) Number
K230024 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Deep-tissue electromagnetic stimulation system, professional

Sano by Beijing Sano Lasers S&T Development 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

K230024 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Beijing Sano Lasers S&T Development Co., Ltd.

Sources (1)

  • FDA UDI e369f3c4-10e3-4e54-9dac-d2c123f0d2e3 34 fields · synced Jun 1, 2026