Is this your brand? Sign in to claim ownership.
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
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (73)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Km Needle | KMS GS0201520 | FDA UDI | Class II | Active |
| Km Needle | KMS BE02540201 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0304020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE03550201 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0255020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE03530201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE01615201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE01815201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE020502010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE030152010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE025502010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE018152010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE035402010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE030302010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE030302020 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0356020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE01840201 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0355020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE035502010 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0256020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE02550201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE020302010 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0204020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE018402010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE030402020 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0254020 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0203020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE025402010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE018302010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE02030201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE03015201 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0354020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE03030201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE030402010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE02515201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE035302010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE03040201 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0305020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE02015201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE020402010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE03060201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE020402020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE035602010 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0353020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE016302010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE016402010 | FDA UDI | Class II | Active |
| Km Needle | KMS BE01630201 | FDA UDI | Class II | Active |
| Km Needle | KMS GS0306020 | FDA UDI | Class II | Active |
| Km Needle | KMS BE02050201 | FDA UDI | Class II | Active |
| Km Needle | KMS BE02530201 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.