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Ballancer Platinum (1222)

by Mego Afek

510(k) K230385

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 NumberK230385 Date4 Apr 2023ClearedStatusActive

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  • Withdrawn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
IRP
Device Class
Class II
Regulation
21 CFR Part 890.5650
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Ballancer Platinum (1222) is a powered inflatable tube massager classified as a Class 2 medical device in the Physical Medicine specialty category. It is designed to provide therapeutic massage through inflatable tube technology.

The device is manufactured by Mego Afek and is supplied as a single-use or reusable product, though specific sterility information is not provided. It is regulated under 21 CFR 890.5650 and received FDA 510(k) clearance on April 4, 2023, with K number K230385.

Other devices from Mego Afek

Questions

AI-generated answers, 26 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 Ballancer Platinum (1222) used for?

    The Ballancer Platinum (1222) is a powered inflatable tube massager designed to provide therapeutic massage. It is classified as a Class 2 medical device in the Physical Medicine specialty category.

  • Is the Ballancer Platinum (1222) single-use or reusable?

    The Ballancer Platinum (1222) is supplied as either a single-use or reusable product, though specific sterility information is not provided in the device data.

  • What regulatory approvals does the Ballancer Platinum (1222) have?

    The Ballancer Platinum (1222) received FDA 510(k) clearance on April 4, 2023, with K number K230385. It is regulated under 21 CFR 890.5650 and is classified as a Class 2 medical device.

  • Who manufactures the Ballancer Platinum (1222)?

    The Ballancer Platinum (1222) is manufactured by Mego Afek, with contact information provided as Yunger Reuven at Kibbuts Afek.