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Back-Tek

by York Biomedical, Inc.

510(k) K101227

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 NumberK101227 Date23 Jun 2010ClearedStatusActive

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  • Withdrawn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
ILY
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The Back-Tek is a portable infrared heated back support. It is designed to provide deep penetrating heat therapy, increase blood flow, and promote healing. The device has a low profile design and is easy to operate.

The Back-Tek is supplied with a 7.4V rechargeable battery and a 120V AC charger. It is a portable device, allowing for easy use in various settings. The device has been cleared by the FDA, with a 510(k) premarket notification, K101227.

Questions

AI-generated answers, 1 Oct 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 Back-Tek used for?

    The Back-Tek is used to provide deep penetrating heat therapy, increase blood flow, and promote healing.

  • Is the Back-Tek portable?

    Yes, the Back-Tek is a portable device, allowing for easy use in various settings, and is supplied with a rechargeable battery and AC charger.

  • How is the Back-Tek powered?

    The Back-Tek is powered by a 7.4V rechargeable battery and can be charged using a 120V AC charger.