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BCS No. 1, Body Care System

by M & A Vertrieb, Liske Und Methling GM

510(k) K881800

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 NumberK881800 Date16 Nov 1988ClearedStatusActive

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  • Withdrawn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
IRT
Device Class
Class II
Regulation
21 CFR Part 890.5740
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 BCS No. 1, Body Care System is a powered heating pad device classified under the Physical Medicine specialty. It is designed for therapeutic use in providing localized heat treatment to the body.

This device received FDA 510(k) clearance (K881800) on November 16, 1988, and was found substantially equivalent to a predicate device. It is manufactured by M & A Vertrieb, Liske Und Methling GM and is assigned product code IRT under regulation 890.5740.

Questions

AI-generated answers, 28 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 BCS No. 1 Body Care System used for?

    The BCS No. 1 Body Care System is a powered heating pad designed for therapeutic use in providing localized heat treatment to the body, intended for physical medicine applications to deliver targeted warmth for symptom relief.

  • How is the BCS No. 1 Body Care System supplied and is it reusable?

    The device is supplied as a powered heating pad unit intended for repeated use; it is not described as single-use in the provided data, and its design supports ongoing therapeutic application with appropriate maintenance between uses.

  • What regulatory pathway was used for the BCS No. 1 Body Care System?

    The BCS No. 1 Body Care System received FDA 510(k) clearance under submission K881800 on November 16, 1988, demonstrating substantial equivalence to a predicate device in the Physical Medicine specialty under product code IRT and regulation 890.5740.