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CoolTone

by Zimmer MedizinSysteme GmbH 4 variants

510(k) K220601

CoolTone is a medical device (FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning) made by Zimmer MedizinSysteme GmbH, cleared under FDA 510(k) K220601 on 1 Apr 2022, active as of 22 Oct 2026.

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK220601 Date1 Apr 2022ClearedStatusActive

Official records

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  • Withdrawn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
NGX
Device class
Class II
Regulation
21 CFR Part 890.5850
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K220601

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K220601
UDI-DISize and differences
CoolTone 5034
Zimmer MedizinSysteme GmbH
CS-MS-002-D-00 / 503404053815076698 —On the market
CoolTone 5040
Zimmer MedizinSysteme GmbH
CS-MS-002-D-CA / 504004053815079187 —On the market

Similar devices

Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Other devices from Zimmer Medizinsystems GmbH

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