CoolTone 5034

by Zimmer MedizinSysteme GmbH

CoolTone 5034 (CS-MS-002-D-00) is a deep-tissue electromagnetic stimulation system (FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning) made by Zimmer MedizinSysteme GmbH, cleared under FDA 510(k) K251378 on 14 Jul 2025 (2 earlier submissions) and listed in FDA GUDID since 4 Dec 2019 (UDI-DI 04053815076698), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

+2 more

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK251378	Date14 Jul 2025Decided	StatusActive
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK220601	Date1 Apr 2022Decided	StatusActive
United States	GUDID listing	Number04053815076698 UDI-DI	Date4 Dec 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Special	NumberK192940	Date15 Nov 2019Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04053815076698
FDA 510(k) database 510(k) number K251378
FDA 510(k) database 510(k) number K220601
FDA 510(k) database 510(k) number K192940

Across registries

2 registries list this device

FDA 510(k) K251378 decided 14 Jul 2025 Active· +2 more in the status table
FDA GUDID UDI-DI 04053815076698 listed 4 Dec 2019 Listed

Timeline

4 dated events

15 Nov 2019 Cleared FDA 510(k) K192940
4 Dec 2019 Listed FDA GUDID 04053815076698
1 Apr 2022 Cleared FDA 510(k) K220601
14 Jul 2025 Cleared FDA 510(k) K251378

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: CoolTone
Generic name: Deep-tissue electromagnetic stimulation system, professional
Model / Ref / Catalog: 5034, CS-MS-002-D-00

Primary DI / UDI-DI: 04053815076698
FDA product code: NGX
GMDN term: Deep-tissue electromagnetic stimulation system, professional

Device class: Class II
Regulation number: 890.5850
GUDID distribution status: In Commercial Distribution

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

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)