Question 1

Who is the manufacturer of HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3?

Accepted Answer

Home Medical Services filed the 510(k) submission for HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3 (K003231).

Question 2

What is the FDA product code for HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3?

Accepted Answer

GZJ. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

Question 3

When was HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3 cleared by the FDA?

Accepted Answer

Jan 12, 2001 (decision: SESE).

Question 4

What is the regulatory pathway for HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K003231
Device Name	HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3
Applicant	Home Medical Services
Product Code	GZJ · Neurology
Decision Date	Jan 12, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2

HMS NEUROMUSCULAR STIMULATOR, MODEL HMS 3

Device Facts

Regulatory Classification

Identification