Intimina KegelSmart 2 Rechargeable

GUDID 07350075029219

The Intimina KegelSmart 2 is a pelvic floor muscle exercise device that provides biofeedback and exercise guidance. Each time the device is used it registers the user's pelvic floor muscle contraction strength and automatically sets a strength level, from 1 to 5, for the following session. Each level has a corresponding exercise routine that is communicated to the user with gentle vibrations.

Leloi AB

Perineometer

• Primary Device ID: 07350075029219
• NIH Device Record Key: 84d73686-fd48-4b9f-88ca-c91cdb136915
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intimina KegelSmart 2 Rechargeable
• Version Model Number: 9219
• Company DUNS: 508701849
• Company Name: Leloi AB
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	07350075029219 [Primary]

FDA Product Code

• HIR: Perineometer

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: 2023-07-04
• Device Publish Date: 2023-06-26

Devices Manufactured by Leloi AB

• 08852961029796 - Lelo Hex Lubricated Natural Rubber Latex Condom 3’s: 2025-04-10 The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pre
• 08852961029802 - Lelo Hex Lubricated Natural Rubber Latex Condom 12’s: 2025-04-10 The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pre
• 08852961029819 - Lelo Hex Lubricated Natural Rubber Latex Condom 36’s: 2025-04-10 The Lelo Hex Lubricated Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pre
• 07350075029578 - HEX Condoms Original 72 Pack (US_TNR): 2023-07-18 The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and
• 07350075028922 - Tor 3 Black: 2023-07-04 Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasu
• 07350075028939 - Tor 3 Base Blue: 2023-07-04 Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasu
• 07350075028946 - Tor 3 Violet Dusk: 2023-07-04 Intended to be placed at the base of the penis where it will stimulate the clitoris of partner to facilitate human sexual pleasu
• 07350075029219 - Intimina KegelSmart 2 Rechargeable: 2023-07-04The Intimina KegelSmart 2 is a pelvic floor muscle exercise device that provides biofeedback and exercise guidance. Each time the device is used it registers the user's pelvic floor muscle contraction strength and automatically sets a strength level, from 1 to 5, for the following session. Each level has a corresponding exercise routine that is communicated to the user with gentle vibrations.
• 07350075029219 - Intimina KegelSmart 2 Rechargeable: 2023-07-04 The Intimina KegelSmart 2 is a pelvic floor muscle exercise device that provides biofeedback and exercise guidance. Each time th