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Model 1100 Cold Therapy Device

by Smith & Nephew, Inc.

510(k) K970533

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970533 Date15 Apr 1997ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
ILO
Device class
Class II
Regulation
21 CFR Part 890.5720
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Model 1100 Cold Therapy Device is a water circulating pack used for cold therapy applications. It is designed to provide therapeutic cold treatment for physical medicine purposes.

The device is supplied by Smith & Nephew, Inc. and has FDA 510(k) clearance with the K number K970533. It is classified as a Class II device under product code ILO and regulation number 890.5720.

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Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Model 1100 Cold Therapy Device used for?

    The Model 1100 Cold Therapy Device is a water circulating pack designed to provide therapeutic cold treatment for physical medicine purposes. It is intended for use in cold therapy applications to help reduce pain and swelling in patients.

  • How is the Model 1100 Cold Therapy Device supplied?

    The device is supplied by Smith & Nephew, Inc. It is a water circulating pack that comes ready for use in cold therapy applications. The device is classified as a Class II medical device under product code ILO.

  • What is the regulatory status of the Model 1100 Cold Therapy Device?

    The Model 1100 Cold Therapy Device has FDA 510(k) clearance with the K number K970533. It was determined to be substantially equivalent to predicate devices and is classified under regulation number 890.5720.

  • Is the Model 1100 Cold Therapy Device reusable or single-use?

    The device description does not specify whether the Model 1100 Cold Therapy Device is reusable or single-use. For information on proper usage and disposal, please refer to the manufacturer's instructions or contact Smith & Nephew, Inc. directly.