Identity
- Trade Name
- Stim-Support Elbow Brace FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Stim-Support Elbow Brace Kit FDA UDI
- Model / Reference
- SSELBW FDA UDI
- Description
- Stim-Support Elbow Brace Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- B872SSELBW0 FDA UDI
- 510(k) Number
- K944487 FDA UDI
- FDA Product Code
- GXY FDA UDI
- GMDN Term
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1320 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Transcutaneous electrical stimulation electrode, single-use
Stim-Support Elbow Brace by Prizm Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K944487 also covers:
- Electro-Mesh Glove — Prizm Medical, Inc.
- Electro-Mesh Glove — Prizm Medical, Inc.
- Electro-Mesh Glove — Prizm Medical, Inc.
- Electro-Mesh Panel — Prizm Medical, Inc.
- Electro-Mesh Panel — Prizm Medical, Inc.
- Electro-Mesh Panel — Prizm Medical, Inc.
- Intelligent Textile Stim-Support Back Wrap — Prizm Medical, Inc.
- Silver-Thera Sock — Prizm Medical, Inc.
- Silver-Thera Sock — Prizm Medical, Inc.
- Silver-Thera Sock — Prizm Medical, Inc.
- Stim-Support Knee Brace — Prizm Medical, Inc.
- Stim-Support Neck Brace — Prizm Medical, Inc.
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
- Prizm Medical, Inc.
Sources (1)
- FDA UDI 5a2f893a-0c3c-438f-8b08-4b2d5ced7908 34 fields · synced May 30, 2026