Identity
- Trade Name
- Perifit FDA UDI
- Generic Name
- Pelvic floor muscle exerciser FDA UDI
- Device Name
- Kegel Exerciser with App FDA UDI
- Model / Reference
- Green Perifit FDA UDI
- Description
- Kegel Exerciser with App FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03770014642660 FDA UDI
- 510(k) Number
- K221476 FDA UDI
- FDA Product Code
- HIR FDA UDI
- GMDN Term
- Pelvic floor muscle exerciser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1425 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
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Pelvic floor muscle exerciser
Perifit by X6 Innovations — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K221476 also covers:
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 |
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Manufacturer
- Manufacturer
- X6 Innovations
Sources (1)
- FDA UDI 9ee57f57-c3a1-4884-a5c6-808b19401588 34 fields · synced Jun 6, 2026