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Smith & Nephew Restim

by Smith & Nephew, Inc.

510(k) K003596

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 NumberK003596 Date6 Jun 2001ClearedStatusActive

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  • Withdrawn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
IPF
Device class
Class II
Regulation
21 CFR Part 890.5850
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Smith & Nephew Restim is a medical device classified under product code IPF. It is intended for use in the field of physical medicine.

This device is authorized via the FDA 510(k) process, having received a decision of substantial equivalence on June 6, 2001. It is identified by reference number K003596.

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Questions

AI-generated answers, 22 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 intended use of the Smith & Nephew Restim?

    The Smith & Nephew Restim is indicated for use within the field of physical medicine. It is classified under product code IPF, which pertains to devices utilized in therapeutic or rehabilitative clinical settings.

  • How was the Smith & Nephew Restim authorized for use?

    The device received authorization through the FDA 510(k) process. It was determined to be substantially equivalent to existing devices on June 6, 2001, under the reference number K003596.

  • Which regulatory advisory committee oversees this device?

    The Smith & Nephew Restim is overseen by the Physical Medicine advisory committee, designated as PM. This committee is responsible for reviewing devices that fall under the scope of physical medicine and rehabilitation applications.