Identity
- Trade Name
- Foot spacer FDA UDI
- Generic Name
- Bedrail FDA UDI
- Device Name
- Electrical Hospital Bed Accessory to fill the gap between the footboard and Assist Grip created when using an extension frame. FDA UDI
- Model / Reference
- KA-H70SU FDA UDI
- Description
- Electrical Hospital Bed Accessory to fill the gap between the footboard and Assist Grip created when using an extension frame. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04527799700301 FDA UDI
- FDA Product Code
- FNL FDA UDI
- GMDN Term
- Bedrail FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5100 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Bedrail
Foot spacer by Paramount Bed Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bedrail.
- Homecare Half Length Bed Rail Cross Bar Mount — Dynarex Corp. · Class I
- ProBasics — COMPASS HEALTH BRANDS CORP. · Class II
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class II
- MERITS — MERITS HEALTH PRODUCTS., INC. · Class I
- INVACARE® ASSIST BAR — Invacare Corp. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Composite Swing Rail — Dynarex Corp. · Class I
- Expansion Kit for D300 — Dynarex Corp. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Paramount Bed Co., Ltd.
Sources (2)
- FDA UDI 3e58eedd-590a-4913-b4b7-66744eeb04fb 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026