Ferno Ille Hi-Lo Jr. Mobile Whirlpool, Model 403

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K914125 ↗

FDA Product Code

ILJ

Device Class

Class II

Regulation

21 CFR Part 890.5100

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K932260 Active Cleared 9 Sep 1993

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  FDA 510(k) K924669 Active Cleared 29 Apr 1993

• Ferno-Washington Incubator Transporter, # 29-It

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  FDA 510(k) K931346 Active Cleared 25 Aug 1993

• What is the Ferno Ille Hi-Lo Jr. Mobile Whirlpool (Model 403) used for?

  This device is a hydrotherapy bath designed specifically for physical medicine applications. It provides immersion therapy with adjustable water levels and massage functions to aid in patient rehabilitation or pain management. The adjustable features allow clinicians to tailor treatment to individual patient needs, making it versatile for various therapeutic goals.

• Is the Ferno Ille Hi-Lo Jr. Mobile Whirlpool (Model 403) single-use or reusable?

  The device is intended for either single-use or reusable applications in clinical settings. However, regulatory documentation does not specify strict sterility requirements beyond standard medical device handling protocols. Clinicians should follow manufacturer guidelines and facility protocols for cleaning, disinfection, and maintenance to ensure safe reuse.

• Can the Ferno Ille Hi-Lo Jr. Mobile Whirlpool (Model 403) be used in MRI environments?

  Yes, the Ferno Ille Hi-Lo Jr. Mobile Whirlpool (Model 403) is non-magnetic and MRI-safe. There are no reported restrictions on its use in magnetic resonance imaging environments, allowing for greater flexibility in clinical settings where MRI compatibility is required.

• What regulatory approval does the Ferno Ille Hi-Lo Jr. Mobile Whirlpool (Model 403) hold?

  The device holds FDA 510(k) clearance under the classification of a Class II hydrotherapy bath, with the clearance number K914125. It is substantially equivalent to the predicate device and adheres to regulatory standards outlined under regulation number 890.5100 for hydrotherapy baths.

• How should the Ferno Ille Hi-Lo Jr. Mobile Whirlpool (Model 403) be stored and maintained?

  Storage and maintenance instructions are manufacturer-specific, but generally involve routine cleaning and inspection to ensure proper function and hygiene. Clinicians should follow the manufacturer’s guidelines and facility protocols for cleaning, disinfection, and maintenance to prolong the device’s lifespan and ensure safe operation.