# Seirin-America, Inc.

- Location (FDA's records): Weymouth, MA
- FDA decisions: 4 (1996–1997): 4 510(k) clearances
- Product codes: MQX (4)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Lhasa Medical, Inc.: 3 (https://510kreport.com/company/lhasa-medical)
- American Institute of Koryo Hand Therapy: 2 (https://510kreport.com/company/american-institute-of-koryo-hand-therapy)
- Lorac, Inc.: 1 (https://510kreport.com/company/lorac)
- Sedatelec: 1 (https://510kreport.com/company/sedatelec)
- Kenshin Trading Corp.: 1 (https://510kreport.com/company/kenshin-trading)

## Its most-cited devices
- K962809: Seirin Acupuncture Needles (1996), cited by 4
- K970254: Seirin Pyonex Acupuncture Needles (1997), cited by 2
- K963769: Seirin Spinex Intradermal Acupuncture Needles (1996), cited by 2

## Recent decisions
- K970260: Seirin JR Acupuncture Needles (Feb 10, 1997)
- K970254: Seirin Pyonex Acupuncture Needles (Feb 10, 1997)
- K963769: Seirin Spinex Intradermal Acupuncture Needles (Oct 16, 1996)
- K962809: Seirin Acupuncture Needles (Aug 16, 1996)

Source page: https://510kreport.com/company/seirin-america