Identity
- Trade Name
- Perifit Care EUDAMEDPerifit FDA UDI
- Generic Name
- Pelvic floor muscle exerciser FDA UDI
- Device Name
- Perifit Care EUDAMEDPerifit Kegel Exerciser with App FDA UDI
- Model / Reference
- Pink EUDAMEDFDA UDI
- Description
- Perifit Kegel Exerciser with App FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770014642110 EUDAMED03770014642004 FDA UDI
- Basic UDI-DI
- 3770014642PER001V5 EUDAMED
- Direct Marketing DI
- 03770014642110 EUDAMED
- FDA Product Code
- KXQ FDA UDI
- EMDN Code
- U070301 PELVIC FLOOR REHABILITATION DEVICES, BIOFEEDBACK, SINGLE-USE EUDAMED
- GMDN Term
- Pelvic floor muscle exerciser FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.5960 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Perifit Care by X6 Innovations — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221476 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K231780 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 3770014642PER001V5 | Class I | Active |
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Manufacturer
- Manufacturer
- X6 Innovations
- EUDAMED SRN
- FR-MF-000029894
Sources (3)
- EUDAMED 640dc09c-b2d5-416e-a96f-922fca03c2a5 85 fields · synced Jun 18, 2026
- FDA UDI 3931ae4e-2a6e-4aa8-8aae-09b84da7c173 34 fields · synced May 30, 2026
- FDA 510(k) K221476 1 fields · synced May 18, 2026