FDA 510(k)

Motive™ Muscle Stimulator for Lower Back (OT01-1003)

K-번호: K253478 · 2025-11-06

결정일2025-11-06

제품 코드NGX

자문 위원회PM

결정Substantially Equivalent

기기 요약

Motive™ Muscle Stimulator for Lower Back (OT01-1003) is the device name listed in this FDA 510(k) record. The listed applicant is Motive Health, Inc.. It received FDA 510(k) clearance on 2025-11-06 under 510(k) number K253478. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Motive™ Muscle Stimulator for Lower Back (OT01-1003)?

Motive™ Muscle Stimulator for Lower Back (OT01-1003) is a medical device that received FDA 510(k) clearance on 2025-11-06. The listed applicant is Motive Health, Inc.. The 510(k) number is K253478.

When did Motive™ Muscle Stimulator for Lower Back (OT01-1003) receive FDA 510(k) clearance?

Motive™ Muscle Stimulator for Lower Back (OT01-1003) received FDA 510(k) clearance on 2025-11-06, under 510(k) number K253478.

Who is the listed applicant for Motive™ Muscle Stimulator for Lower Back (OT01-1003)?

The FDA 510(k) record lists Motive Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Motive™ Muscle Stimulator for Lower Back (OT01-1003)?

The FDA product code for Motive™ Muscle Stimulator for Lower Back (OT01-1003) is NGX.

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Motive™ Muscle Stimulator for Lower Back (OT01-1003)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: NGX)

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