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510(k) K220601

CoolTone by Zimmer Medizinsysteme GmbH — Product Code NGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2022
Date Received
March 2, 2022
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

Other clearances by Zimmer Medizinsysteme GmbH

  • K253408 — CoolTone (January 16, 2026)
  • K251378 — CoolTone (July 14, 2025)
  • K240347 — PTG-05 (July 21, 2024)
  • K240178 — RFG-01 (July 15, 2024)
  • K230780 — MFG-05 (October 5, 2023)
  • K213256 — ThermoTK (May 25, 2023)
  • K222912 — c1Trac (May 16, 2023)
  • K220020 — Cryo 7 (February 4, 2022)
  • K203488 — emField (February 19, 2021)
  • K192940 — CoolTone (November 15, 2019)

Other clearances for product code NGX

  • K253636 — Zionic Pro Max (EMS) (March 12, 2026)
  • K253408 — CoolTone (January 16, 2026)
  • K252154 — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-232 (December 9, 2025)
  • K253478 — Motive™ Muscle Stimulator for Lower Back (OT01-1003) (November 6, 2025)
  • K251594 — truFlex (August 28, 2025)
  • K251706 — TENS and EMS Unit (July 30, 2025)
  • K251378 — CoolTone (July 14, 2025)
  • K251746 — Pure Impact (July 2, 2025)
  • K250759 — 3 in 1 TENS UNIT (June 13, 2025)
  • K242926 — XBody Go USA, XBody Pro USA (May 30, 2025)