Raye'S, Inc.

United StatesFDA applicant, unverified

Devices: 3
FDA recalls: 21 ongoing

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Raye'S, Inc. makes

Raye'S, Inc. manufactures mobility aids, including a multi-functional rehabilitation chair designed for clinical and home use, as well as the Prairie Cruiser and Overlander PEV 2000—power-enabled vehicles for outdoor mobility and transport.

The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. Raye'S, Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

Multi Fuctional Rehabilitation Chair Ref K022407

Active Regimes: 510(k) Registry: 510(k) Class:II
Prairie Cruiser Ref K002580

Active Regimes: 510(k) Registry: 510(k) Class:II
Overlander Pev 2000 Ref K983497

Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 2 recalls initiated by Raye'S, Inc., the earliest on 2005-11-14 and the most recent on 2024-01-25. By recorded status: 1 ongoing and 1 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 0
2023 0
2024 1
2025 0
2026 0

1 initiated before 2017

2024
- 25 Jan 2024 Z-1595-2024 Class II Ongoing Retrospective engineering analysis against current ISO standards for hoists has determined: 1. The device cannot physically perform at maximum documented weight specifications when a factor of safety of two times the maximum load is applied. 2. The device is not equipped with a safety device to ensure a person with disability would not fall in the event of a single-fault condition of the lifting device. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, UK.
2005
- 14 Nov 2005 Z-0908-06 Unclassified (pre-2012) Terminated The bed may drop due to a malfunction of the actuator exceeding its stop. Distribution: The beds were shipped to the nationwide customers of their one consignee who is located in KS.

Frequently asked questions

How many devices does Raye'S, Inc. have in the registry?

The registry currently lists 3 devices for Raye'S, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Raye'S, Inc.'s devices?

Among its 3 most recently registered devices, Raye'S, Inc. has devices listed in FDA 510(k) (3 devices).

What risk classes do Raye'S, Inc.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Raye'S, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Raye'S, Inc.?

FDA recall records list 2 recalls initiated by Raye'S, Inc., the most recent initiated on 25 Jan 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Raye'S, Inc. in the registry?

The most recently registered devices listed for Raye'S, Inc. include MULTI FUCTIONAL REHABILITATION CHAIR, PRAIRIE CRUISER and OVERLANDER PEV 2000.

Generated automatically from registry data and not verified by a human reviewer.