Microair Pup
510(k) K925694
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK925694 | Date24 Mar 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- IOQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5170
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Microair Pup is a Bed, Flotation Therapy, Powered, classified under FDA regulation 890.5170. This device is designed for flotation therapy, utilizing air pressure to support the body in a buoyant environment, which aids in physical medicine applications such as pain management, muscle relaxation, and rehabilitation. Its primary function is to provide controlled flotation to reduce joint stress and promote therapeutic positioning for patients.
The Microair Pup is supplied as a reusable medical device and is intended for use in clinical settings such as physical medicine clinics or rehabilitation centers. It operates under standard environmental conditions and does not require sterile packaging. The device is regulated under FDA 510(k) clearance (K925694) with a classification of Class II, granted as substantially equivalent (SESE) to a predicate device. No specific MRI safety or single-use restrictions are noted in the regulatory filings.
Questions
AI-generated answers, 1 Oct 2026
What is the Microair Pup flotation therapy bed used for?
The Microair Pup is a powered flotation therapy bed designed to provide controlled air pressure support for the body. This creates a buoyant environment that reduces joint stress, promotes therapeutic positioning, and aids in physical medicine applications such as pain management, muscle relaxation, and rehabilitation. It is particularly useful in clinical settings like physical medicine clinics or rehabilitation centers.
Is the Microair Pup a single-use or reusable device?
The Microair Pup is a reusable medical device. It is intended for repeated use in clinical settings and does not require sterile packaging for each application. This makes it cost-effective for ongoing therapy programs in physical medicine or rehabilitation environments.
What regulatory approval does the Microair Pup hold?
The Microair Pup holds FDA 510(k) clearance under the classification of Class II, with a decision code of Substantially Equivalent (SESE). This clearance was granted as substantially equivalent to a predicate device, ensuring it meets regulatory standards for flotation therapy beds in physical medicine applications.
What are the key specifications or models associated with the Microair Pup?
The Microair Pup is associated with multiple registration numbers and FEI numbers, including 3014650138, 3011489684, and others listed under the OpenFDA database. These identifiers correspond to its classification under FDA regulation 890.5170 and its use in physical medicine. The device operates under standard environmental conditions and does not have specific MRI safety restrictions noted in regulatory filings.
Does the Microair Pup require special storage conditions?
The Microair Pup is designed for use in standard clinical environments and does not have documented special storage requirements beyond typical medical device maintenance. Since it is reusable and not sterile-packaged, it should be cleaned and maintained according to manufacturer guidelines to ensure proper functionality and hygiene for repeated use in physical medicine or rehabilitation settings.