Identity
- Trade Name
- HOMEDICS FDA UDI
- Generic Name
- Pneumatic massager FDA UDI
- Device Name
- Single Real Relief Calf Compression Massager FDA UDI
- Model / Reference
- SR-109HJ FDA UDI
- Description
- Single Real Relief Calf Compression Massager FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00031262109217 FDA UDI
- 510(k) Number
- K221862 FDA UDI
- FDA Product Code
- IRP FDA UDI
- GMDN Term
- Pneumatic massager FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5650 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pneumatic massager
Homedics by Fka Distributing Co., Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pneumatic massager.
- Compressible Limb Therapy System(LX7(V7)) — DAESUNG MAREF CO., LTD. · Class II
- Compressible Limb Therapy System(MK300L) — DAESUNG MAREF CO., LTD. · Class II
- Compressible Limb Therapy System(LX7(V7)) — DAESUNG MAREF CO., LTD. · Class II
- Compressible Limb Therapy System — DAESUNG MAREF CO., LTD. · Class II
- Compressible Limb Therapy System — DAESUNG MAREF CO., LTD. · Class II
- medisana — ZHANGZHOU EASEPAL INNOVATION CO., LTD. · Class II
- Homedics — Huizhou Xinyi Technology Co., Ltd. · Class II
- Compressible Limb Therapy System — DAESUNG MAREF CO., LTD. · Class II
Cleared under the same submission
K221862 also covers:
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
- Fka Distributing Co., Llc
Sources (1)
- FDA UDI 9c5c4bb8-91e9-49fe-8883-ed40731cb8fb 34 fields · synced Jun 8, 2026