Identity
- Trade Name
- Attain FDA UDI
- Generic Name
- Pelvic floor muscle exerciser FDA UDI
- Device Name
- Attain FDA UDI
- Model / Reference
- 3200000A1 FDA UDI
- Description
- Attain FDA UDI
Identifiers
- Catalog Number
- 3200000A1 FDA UDI
- Primary DI / UDI-DI
- 00851508007103 FDA UDI
- 510(k) Number
- K182022 FDA UDI
- FDA Product Code
- KPI FDA UDI
- GMDN Term
- Pelvic floor muscle exerciser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5320 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 4.1 Inch FDA UDI
Category: Pelvic floor muscle exerciser
Attain by Incontrol Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Bloom — SWORD HEALTH, S.A. · Class II
- U-Control 60Hz Unit TT — 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 |
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Manufacturer
- Manufacturer
- Incontrol Medical, Llc
Sources (1)
- FDA UDI 865e6fda-de88-49d0-abd8-aadbc887cb7e 38 fields · synced May 30, 2026