Identity
- Trade Name
- Stim-Support Shoulder - XL FDA UDI
- Generic Name
- Transcutaneous electrical stimulation electrode, single-use FDA UDI
- Device Name
- Stim-Support Shoulder Kit FDA UDI
- Model / Reference
- SSS 2305 FDA UDI
- Description
- Stim-Support Shoulder Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- B872SSS23050 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
- Not 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
Stim-Support Shoulder - XL by Prizm Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 Elbow Brace — Prizm Medical, Inc.
- Stim-Support Knee 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prizm Medical, Inc.
Sources (1)
- FDA UDI 731f142d-a881-4ce3-ad77-ef410b0f8424 35 fields · synced Jun 1, 2026