Model 700 Low Pressure Mattress
510(k) K934817
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK934817 | Date17 Jun 1994 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Surgical Design Corporation Model 700 Low Pressure Mattress
- 510(k) Number
- FDA Product Code
- FNM
- FDA applicant
- Surgical Design Corp.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5550
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Model 700 Low Pressure Mattress is an alternating pressure air flotation mattress, classified as a Class II medical device. It consists of a mattress with multiple air cells that alternate between inflation and deflation via an associated control unit, promoting even pressure redistribution to support patient comfort and prevent pressure injuries.
This device is intended for use in general hospital settings and is supplied as a reusable, non-sterile item. It requires connection to an external power source for operation and is regulated under FDA 510(k) clearance (K934817), with a decision classification of Substantially Equivalent. No MRI safety or single-use specifications are indicated in the regulatory data.
Other devices from Surgical Design, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Model 700 Low Pressure Mattress and where is it typically used?
The Model 700 Low Pressure Mattress is designed to alternate air pressure in its cells to promote even pressure redistribution, supporting patient comfort and helping prevent pressure injuries. It is intended for use in general hospital settings, particularly for patients requiring long-term or specialized bed support.
Is the Model 700 Low Pressure Mattress single-use or reusable, and what does that mean for maintenance?
The Model 700 Low Pressure Mattress is a reusable device, meaning it is not intended for one-time use. This allows for repeated use across multiple patients, but it requires proper cleaning, disinfection, and maintenance between uses to ensure safety and functionality. The manufacturer’s guidelines should be followed for cleaning protocols.
Does the Model 700 Low Pressure Mattress come sterile, and if not, what considerations should be taken for patient use?
The Model 700 Low Pressure Mattress is supplied as a non-sterile item. Since it is reusable, it must be cleaned and disinfected between patients to maintain hygiene standards. Clinicians should follow hospital infection control protocols to ensure proper sterilization or disinfection before each use.
How is the Model 700 Low Pressure Mattress powered, and what does this mean for its operation?
The Model 700 Low Pressure Mattress requires connection to an external power source for operation. This means it cannot function without a reliable electrical supply, so facilities must ensure proper power availability and backup systems if needed to maintain continuous use.
What regulatory pathway was followed for the Model 700 Low Pressure Mattress, and what does this indicate about its approval status?
The Model 700 Low Pressure Mattress was cleared through the FDA’s 510(k) pathway, specifically under clearance number K934817, with a decision classification of *Substantially Equivalent*. This indicates that the device was determined to be as safe and effective as a legally marketed predicate device, though it does not imply current active approval status beyond the original clearance date.