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FDA 510(k)

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

K-Number: K253478 · 2025-11-06

ApplicantMotive Health, Inc.
Decision Date2025-11-06
Product CodeNGX
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06012110Transcutaneous Electrical Stimulation for Spasticity in Patients With Primary Lateral SclerosisCOMPLETED

Related Devices (Code: NGX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253790High Intensity Focused Electromagnetic Stimulation Device (FE60)Beijing Winkonlaser Technology LimitedK253926DiacoreShenB Co., Ltd.K253636Zionic Pro Max (EMS)Termosalud S.L.K253408CoolToneZimmer Medizinsysteme GmbHK252154Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP)Guangzhou Longest Medical Technology Co., Ltd.K251594truFlexSyrma Johari Medtech Limited

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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