Identity
- Trade Name
- Smart Rail 1 Pack FDA UDI
- Generic Name
- Bedrail FDA UDI
- Device Name
- The Smart-Rail is a bed rail with 2 positions: closed and opened. In the closed position, the rail is latched to the support frame to assist with in-bed positioning. In the opened position, the rail is unlatched from the support frame and pivoted out to the optimal location to assist with sitting and standing. The Smart-Rail is intended ONLY for moderate vertical load bearing to provide bed positioning, sitting and standing support for people with reduced mobility. The Smart-Rail is installed between the mattress and box spring, and is secured in place with a safety strap. In the closed position, the Smart-Rail is height adjustable to accommodate the thickness of the mattress. In the opened position, the Smart-Rail is height adjustable to accommodate the height of the user. The maximum user weight for this product is 300lbs / 136kgs. Product is not intended to support full body weight. FDA UDI
- Model / Reference
- SRS-S-1PK FDA UDI
- Description
- The Smart-Rail is a bed rail with 2 positions: closed and opened. In the closed position, the rail is latched to the support frame to assist with in-bed positioning. In the opened position, the rail is unlatched from the support frame and pivoted out to the optimal location to assist with sitting and standing. The Smart-Rail is intended ONLY for moderate vertical load bearing to provide bed positioning, sitting and standing support for people with reduced mobility. The Smart-Rail is installed between the mattress and box spring, and is secured in place with a safety strap. In the closed position, the Smart-Rail is height adjustable to accommodate the thickness of the mattress. In the opened position, the Smart-Rail is height adjustable to accommodate the height of the user. The maximum user weight for this product is 300lbs / 136kgs. Product is not intended to support full body weight. FDA UDI
Identifiers
- Catalog Number
- 01984 FDA UDI
- Primary DI / UDI-DI
- 00689281019842 FDA UDI
- FDA Product Code
- IKX FDA UDI
- GMDN Term
- Bedrail FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5050 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
Smart Rail 1 Pack by Healthcraft Products Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Healthcraft Products Inc.
Sources (1)
- FDA UDI 42abd9da-f5ae-4898-9a51-afbb28afa0fb 34 fields · synced Jun 8, 2026