Identity
- Trade Name
- Pelvifine FDA UDI
- Generic Name
- Pelvic floor muscle exerciser FDA UDI
- Model / Reference
- KM500 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970935830710 FDA UDI
- FDA Product Code
- KXQ FDA UDI
- GMDN Term
- Pelvic floor muscle exerciser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.5960 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pelvic floor muscle exerciser
Pelvifine by Shenzhen Konmed Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pelvic floor muscle exerciser.
- Sword Bloom — SWORD HEALTH, S.A. · Class II
- Attain — INCONTROL MEDICAL, LLC · Class II
- Apex®M by Viveve — INCONTROL MEDICAL, LLC · Class II
- Apex®M — INCONTROL MEDICAL, LLC · Class II
- Hinge Health Pelvic Trainer by Perifit — X6 INNOVATIONS · Class II
- Perifit Care — X6 INNOVATIONS · Class II
- Meet Blossom — SWORD HEALTH, S.A. · Class II
- Vaginal Sensor Unit TTL — Thought Technology Ltd. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Konmed Technology Co., Ltd.
Sources (1)
- FDA UDI 481f4c51-ccd8-4574-adf5-c750c57fec1e 32 fields · synced May 30, 2026