WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2026 / K261079

510(k) cleared

Power Wheelchair (DC12)

Anhui JBH Medical Apparatus Co., Ltd. · Oct 6, 2026 · K261079

FDA cleared the Power Wheelchair (DC12) from Anhui JBH Medical Apparatus Co., Ltd. on Oct 6, 2026 under K261079, a traditional 510(k). The device falls under product code ITI, Wheelchair, Powered, regulated at 21 CFR 890.3860 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Apr 1, 2026. The decision came 188 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Anhui JBH Medical Apparatus Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261200 (Power Wheelchair (D60)), K261078 (Electric Scooter (FNS01,FNS03)), K261859 (Electric Scooter (FDB08, FDB08A, FDB12)).

Questions & Answers

What did FDA clear under K261079?

K261079 is the FDA 510(k) for Power Wheelchair (DC12), submitted by Anhui JBH Medical Apparatus Co., Ltd.. FDA's decision date was Oct 6, 2026, under product code ITI (Wheelchair, Powered).

Who makes the Power Wheelchair (DC12)?

Anhui JBH Medical Apparatus Co., Ltd., based in Chuzhou, is the applicant of record for K261079.

How long did the K261079 review take?

FDA received the submission on Apr 1, 2026 and issued its decision on Oct 6, 2026, 188 days later.

← All decisions in October 2026

Sources