9TH Wave Model 200 Alternating Pressure Pad
510(k) K963677
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK963677 | Date26 Nov 1996 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- FNM
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5550
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Model 200 Alternating Pressure Pad is an Mattress, Air Flotation, Alternating Pressure, designed to reduce pressure ulcers by cyclically inflating and deflating interconnected air cells. This device distributes body weight across multiple support surfaces, promoting circulation and comfort for patients at risk of pressure injuries, particularly in general hospital settings.
This reusable device is intended for use in hospital environments and has undergone FDA review under 510(k) clearance (K963677) as substantially equivalent to predicate devices. Supplied with an associated control unit, it operates on alternating pressure cycles to maintain patient positioning. The device is classified as Class II under regulation 880.5550 and is not intended for MRI use. No third-party review was required for this submission.
Other devices from 9th Wave, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of the 9th Wave Model 200 Alternating Pressure Pad?
The Model 200 Alternating Pressure Pad is designed to reduce the risk of pressure ulcers by cyclically inflating and deflating interconnected air cells. This mechanism distributes body weight across multiple support surfaces, promoting better circulation and patient comfort, particularly for individuals at risk of pressure injuries in general hospital settings.
How is the Model 200 Alternating Pressure Pad supplied and used?
The device is supplied as a reusable mattress paired with an associated control unit. It operates through alternating pressure cycles to maintain patient positioning, ensuring continuous support and pressure relief. The control unit manages the inflation and deflation of the air cells to optimize patient care.
Is the Model 200 Alternating Pressure Pad intended for single-use or reuse?
The Model 200 Alternating Pressure Pad is explicitly designed for reuse. It is built to withstand repeated use in hospital environments, provided it is properly maintained and cleaned according to manufacturer guidelines. This makes it a cost-effective solution for long-term patient care.
Can the Model 200 Alternating Pressure Pad be used in MRI environments?
No, the Model 200 Alternating Pressure Pad is explicitly not intended for MRI use. The device’s materials and construction are not compatible with magnetic resonance imaging environments, so it should only be used in non-MRI settings.
What regulatory pathway was followed for the Model 200 Alternating Pressure Pad?
The Model 200 Alternating Pressure Pad underwent FDA review under a 510(k) clearance (K963677), demonstrating substantial equivalence to predicate devices. It is classified as a Class II medical device under regulation 880.5550 and is intended for use in general hospital settings. No third-party review was required for this submission.