Identity
- Trade Name
- SenseRx -- Anal/Small Vaginal and Vaginal EMG FDA UDI
- Generic Name
- Perineometer FDA UDI
- Device Name
- Perineometer -- SenseRx -- Anal/Small Vaginal and Vaginal EMG FDA UDI
- Model / Reference
- 4510C FDA UDI
- Description
- Perineometer -- SenseRx -- Anal/Small Vaginal and Vaginal EMG FDA UDI
Identifiers
- Catalog Number
- 4510C FDA UDI
- Primary DI / UDI-DI
- 08519520070003 FDA UDI
- 510(k) Number
- K002834 FDA UDI
- FDA Product Code
- HIR FDA UDI
- GMDN Term
- Perineometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1425 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
SenseRx -- Anal/Small Vaginal and Vaginal EMG by Personal Medical Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Personal Medical Corp.
Sources (1)
- FDA UDI b4a94292-9f2f-41c1-b5b7-69e9be9462f9 37 fields · synced May 30, 2026