Identity
- Trade Name
- SIM™ kit FDA UDI
- Generic Name
- Incontinence sensor/alarm FDA UDI
- Device Name
- SIM™ kit (EU) that contains: - SIM™ pod kit; - SIM™ tablet; - SIM™ tablet accessories; FDA UDI
- Model / Reference
- 6033 FDA UDI
- Description
- SIM™ kit (EU) that contains: - SIM™ pod kit; - SIM™ tablet; - SIM™ tablet accessories; FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09342124000629 FDA UDI
- 510(k) Number
- K130951 FDA UDI
- FDA Product Code
- KPN FDA UDI
- GMDN Term
- Incontinence sensor/alarm FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.2040 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Incontinence sensor/alarm
SIM™ kit by Simavita (aust) Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Incontinence sensor/alarm.
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- Malem — MALEM MEDICAL LIMITED · Class II
- Malem — MALEM MEDICAL LIMITED · Class II
- Chummie — THEOS MEDICAL SYSTEMS, INC. · Class II
- Chummie — THEOS MEDICAL SYSTEMS, INC. · Class II
- Malem — MALEM MEDICAL LIMITED · Class II
- Parasol Wireless Patient Fall Prevention System — PARASOL MEDICAL · Class I
Cleared under the same submission
K130951 also covers:
- SIM assess sensor pad Heavy — SIMAVITA (AUST) PTY LTD
- SIM assess sensor pad Light — SIMAVITA (AUST) PTY LTD
- SIM assess sensor pad Moderate — SIMAVITA (AUST) PTY LTD
- SIM assess sensor pad kit - HEAVY — SIMAVITA (AUST) PTY LTD
- SIM assess sensor pad kit - LIGHT — SIMAVITA (AUST) PTY LTD
- SIM assess sensor pad kit - MODERATE — SIMAVITA (AUST) PTY LTD
- SIM assessPLUS sensor pad Heavy — SIMAVITA (AUST) PTY LTD
- SIM assessPLUS sensor pad Light — SIMAVITA (AUST) PTY LTD
- SIM assessPLUS sensor pad Moderate — SIMAVITA (AUST) PTY LTD
- SIM assessPLUS sensor pad kit - HEAVY — SIMAVITA (AUST) PTY LTD
- SIM assessPLUS sensor pad kit - LIGHT — SIMAVITA (AUST) PTY LTD
- SIM assessPLUS sensor pad kit - MODERATE — SIMAVITA (AUST) PTY LTD
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
- Simavita (aust) Pty Ltd
Sources (1)
- FDA UDI 5e1f7c4d-2702-48e9-9689-ed903392bb75 34 fields · synced May 30, 2026