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Sign in to claim this brandK.M.S., Inc.
US
Last updated May 23, 2026
What K.M.S., Inc. makes
K.M.S., Inc. manufactures single-use acupuncture needles designed for medical and therapeutic procedures. The needles are intended for insertion into the skin to stimulate specific points for pain relief, relaxation, or other therapeutic effects.
The company’s products fall under FDA Class II regulation and are listed via 510(k) clearance and the FDA’s Unique Device Identification (UDI) system. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does K.M.S., Inc. manufacture?
K.M.S., Inc. specializes in single-use acupuncture needles. These needles are intended for medical and therapeutic procedures, such as stimulating specific points in the skin for pain relief, relaxation, or other therapeutic purposes. The company’s focus is exclusively on this category of devices.
Where is K.M.S., Inc. based, and what does that mean for its regulatory oversight?
K.M.S., Inc. is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies these needles as Class II, which means they undergo specific controls to ensure safety and effectiveness, including premarket notifications (510(k)) and compliance with the UDI system.
Which regulatory registries or databases list K.M.S., Inc.’s devices?
K.M.S., Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identification (UDI) system. These registries help track and verify the compliance and authorization status of medical devices, ensuring transparency for healthcare providers and regulators.
How are K.M.S., Inc.’s acupuncture needles classified by regulatory authorities?
K.M.S., Inc.’s acupuncture needles are classified as FDA Class II devices. This classification means they are considered to have a moderate level of control required to ensure their safety and performance. Class II devices typically require premarket submissions (like 510(k)s) and ongoing compliance with FDA regulations, including labeling and manufacturing controls.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (73)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Km Needle | KMS BE03550201 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0253020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE03560201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE020152010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE025302020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE020302020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE025152010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE030602010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE025402020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE02040201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE035502010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE03540201 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0205020 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0251520 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0303020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE02560201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE01830201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE025302010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE016152010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE025602010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE01640201 | FDA UDI | Class II | Active |
| Setup Computer With Software V-1261, 62 And 63 | K914698 | FDA 510(k) | Class II | Active |
| KM Needles (Acupuncture Needle) | K142920 | FDA 510(k) | Class II | Active |
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