Bx-500 Electronic Muscle Exerciser

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K822287 ↗

FDA Product Code

IPF

Device Class

Class II

Regulation

21 CFR Part 890.5850

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• Slendertone

  Class II

  FDA 510(k) K790120 Active Cleared 7 May 1979

• Bx-400 Jesse Jimbody

  Class II

  FDA 510(k) K813410 Active Cleared 8 Mar 1982

• Electronic Muscle Exercise Equipment (K841779)

  Class II

  FDA 510(k) K841779 Active Cleared 30 May 1984

• Bx-400

  Class II

  FDA 510(k) K842142 Active Cleared 25 Jun 1984

• Model P-8 Professional

  Not classified

  FDA 510(k) K811114 Active Cleared 23 Nov 1981

• Bx-400 Sport

  Class II

  FDA 510(k) K813443 Active Cleared 8 Mar 1982

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