Skytron Model 610-2

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K870045 ↗

FDA Product Code

INX

Device Class

Class II

Regulation

21 CFR Part 890.5160

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Stellar

  Class II

  FDA 510(k) K002463 Active Cleared 8 Nov 2000

• Skytron Elite 300 Surgery Table

  Class I

  FDA 510(k) K853479 Active Cleared 5 Sep 1985

• Skytron Universe Series Surgical Lights

  Class II

  FDA 510(k) K900211 Active Cleared 19 Mar 1990

• Skytron Model 130 Surgical Table

  Class I

  FDA 510(k) K873478 Active Cleared 24 Sep 1987

• Skytron Elite Surgical Tables

  Class II

  FDA 510(k) K811311 Active Cleared 2 Jun 1981

• Skytron Life Island 21

  Class II

  FDA 510(k) K926045 Active Cleared 27 Jul 1993

See all devices from Skytron, Div. the Kmw Group, Inc. →

• What is the Skytron Model 610-2 Air Fluidized Bed used for?

  The Skytron Model 610-2 is designed to provide a supportive, pressure-relieving surface for patients in clinical settings like physical medicine departments and rehabilitation centers. By using air fluidization technology, it evenly distributes body weight, reducing the risk of pressure ulcers and improving patient comfort during prolonged use. This makes it ideal for managing patient positioning and mobility in environments where extended bed rest or limited movement is required.

• Is the Skytron Model 610-2 reusable or single-use?

  The Skytron Model 610-2 is a reusable device. It requires regular maintenance and cleaning to ensure sterility and proper functionality. Unlike single-use devices, this model is built for repeated clinical use, provided it is properly cared for and serviced according to manufacturer guidelines.

• What maintenance or cleaning protocols are required for the Skytron Model 610-2?

  Since the Skytron Model 610-2 is reusable, it must undergo proper cleaning and maintenance to prevent contamination and ensure longevity. The manufacturer provides specific protocols for disinfection and upkeep, which typically include regular washing with approved disinfectants, drying, and inspection for wear or damage. Adhering to these protocols is essential to maintain sterility and performance in clinical settings.

• Can the Skytron Model 610-2 be used in an MRI environment?

  No, the Skytron Model 610-2 is not MRI-safe. If used in a facility with MRI capabilities, it must be positioned outside the MRI scanning area to avoid interference or safety risks. Always verify compatibility with MRI equipment and follow facility protocols for non-MRI-safe devices.

• What regulatory approval does the Skytron Model 610-2 hold?

  The Skytron Model 610-2 holds FDA 510(k) clearance under the classification of a Class II medical device (regulation number 890.5160). It was granted substantial equivalence by the FDA’s Physical Medicine Advisory Committee on February 4, 1987, with clearance number K870045. This approval confirms its compliance with U.S. regulatory standards for air fluidized beds intended for physical medicine applications.