A-2000 BATHING SYSTEMS - A-2000 Bathing Systems
by Medi-Man Rehabilitation Products, Inc.
510(k) K992779
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992779 | Date13 Jan 2000 | 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- Withdrawn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
- ILJ
- Models / Variants
- A-2000 Bathing Systems
- Device Class
- Class II
- Regulation
- 21 CFR Part 890.5100
- Advisory Committee
- Physical Medicine
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The A-2000 Hydrosonic Bathing System is a hydro-massage bath designed for bathing disabled individuals. Classified as a hydro-massage bath under the FDA’s nomenclature, it provides mechanical assistance to facilitate hygiene for patients with limited mobility, incorporating hydrosonic technology to enhance the bathing process.
This device is intended for use in clinical or rehabilitation settings by caregivers. Supplied as a reusable system, it requires proper cleaning and maintenance to ensure sterility and functionality. Authorized under FDA 510(k) clearance (K992779), the system falls under Class II medical devices and adheres to regulatory standards for physical medicine applications. No third-party certification is indicated.
Other devices from Medi-Man Rehabilitation Products, Inc.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the A-2000 Hydrosonic Bathing System and where is it typically used?
The A-2000 Hydrosonic Bathing System is designed to assist caregivers in bathing individuals with limited mobility by providing mechanical and hydrosonic support. It is specifically intended for clinical or rehabilitation settings, where patients may require additional help during hygiene routines due to physical constraints.
Is the A-2000 Hydrosonic Bathing System single-use or reusable, and what maintenance is required?
The A-2000 Hydrosonic Bathing System is supplied as a reusable device. To ensure sterility and functionality, it requires proper cleaning and maintenance as part of its operational protocol, which is critical for safe and repeated use in clinical environments.
What regulatory pathway was followed for the FDA clearance of this device, and what class does it belong to?
The A-2000 Hydrosonic Bathing System received FDA clearance through a Traditional 510(k) pathway, specifically under K992779, and is classified as a Class II medical device. The clearance was granted by the FDA’s Physical Medicine (PM) Advisory Committee and is substantively equivalent to a predicate device, adhering to regulatory standards for physical medicine applications.
Does this device require third-party certification, and what are the key specifications or features that define it?
No third-party certification is indicated for the A-2000 Hydrosonic Bathing System. It is defined as a hydro-massage bath under FDA nomenclature, incorporating hydrosonic technology to aid in bathing disabled individuals by providing mechanical assistance. The system is designed for use in clinical or rehabilitation settings to enhance hygiene for patients with limited mobility.