SANO

GUDID 06973511890061

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.

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

Deep-tissue electromagnetic stimulation system, professional

• Primary Device ID: 06973511890061
• NIH Device Record Key: 52319bef-cc62-4752-9bdd-2307c01f4080
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SANO
• Version Model Number: SHE-MSP002
• Company DUNS: 414243850
• Company Name: Beijing Sano Lasers S&T Development Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973511890061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230024

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-23
• Device Publish Date: 2024-05-15

On-Brand Devices [SANO]

• 06973511890092: The proposed device is a type of the most advanced electromagnetic,non-invasive treatment machin
• 06973511890085: The proposed device is a type of the most advanced electromagnetic,non-invasive treatment machin
• 06973511890078: Cryojet Plus is intended to minimize pain and thermal injury during laser and dermatological tre
• 06973511890061: The proposed device is a type of the most advanced electromagnetic,non-invasive treatment machin
• 06973511890009: The proposed device, Diode Laser Hair Removal System, is a surgical device, which is intended fo
• 06973511890108: CO2 laser is monochromatic light with strong penetration and precise focusing; When a continuous