NRW · Stimulator, Intramuscular, Automatic
General Hospital · 21 CFR 880.5580 · Class 2
Overview
| Product Code | NRW |
|---|---|
| Device Name | Stimulator, Intramuscular, Automatic |
| Regulation | 21 CFR 880.5580 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.
Classification Rationale
Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:
Special Controls
*Classification.* Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109, (2) Device material biocompatibility, and (3) Device sterility.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K040580 | AIS100 AUTOMATIC INTRAMUSCULAR STIMULATOR | D.Y. Instrument, Inc. | Aug 26, 2004 | SESE |
Top Applicants
- D.Y. Instrument, Inc. — 1 clearance
