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Parallel Bars Electric Platform Mount EPB10080B-NE

by Pivotal Health Solutions

Parallel Bars Electric Platform Mount EPB10080B-NE is a Class I device made by Pivotal Health Solutions, listed in FDA GUDID since 22 Jan 2026 (UDI-DI 00854798000472), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00854798000472 UDI-DI Date22 Jan 2026ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Parallel Bars Electric Platform Mount
Generic name
Parallel bar exerciser, powered
Model / reference
EPB10080B-NE
Primary DI / UDI-DI
00854798000472
FDA product code
IRR
GMDN term
Parallel bar exerciser, powered
Device class
Class I
Regulation number
890.5380
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)