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Bioelectrical Impedance Analyzer #101

by Rjl Systems, Inc.

510(k) K830292

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 NumberK830292 Date12 Aug 1983ClearedStatusActive

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  • Withdrawn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
DSB
Device Class
Class II
Regulation
21 CFR Part 870.2770
Advisory Committee
Cardiovascular
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.

This device is a plethysmograph, impedance, used for bioelectrical impedance analysis. It is classified as a Class II medical device and is substantially equivalent to a predicate device.

It was cleared via the traditional 510(k) pathway under regulation number 870.2770, with product code DSB. The device is intended for cardiovascular applications and was manufactured by Rjl Systems, Inc. in Walker, MI.

Other devices from Rjl Systems, Inc.

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 BIOELECTRICAL IMPEDANCE ANALYZER #101 used for?

    The BIOELECTRICAL IMPEDANCE ANALYZER #101 is a plethysmograph impedance device intended for bioelectrical impedance analysis in cardiovascular applications, as indicated by its classification under regulation number 870.2770 and product code DSB.

  • How was the BIOELECTRICAL IMPEDANCE ANALYZER #101 cleared for market?

    The device was cleared via the traditional 510(k) pathway under k-number K830292, demonstrating substantial equivalence to a predicate device, as reflected in the decision code SESE and decision description 'Substantially Equivalent'.

  • Who manufactures the BIOELECTRICAL IMPEDANCE ANALYZER #101 and where is it located?

    The BIOELECTRICAL IMPEDANCE ANALYZER #101 is manufactured by Rjl Systems, Inc., located at 4221 Richmond Rd., NW, Walker, MI 49534, United States, as shown in the address, city, state, postal code, and country code fields.