The following data is part of a premarket notification filed by Maanshan Bond Medical Instruments Co., Ltd. with the FDA for Eacu, Zagu, Jocu, Eaku, Balance, Tempo, Acuzone, Smart, Prime, Acustar, Acuking, Myotech Dry, Red Coral Premium, Red Coral J-type, Red Coral Natural.
| Device ID | K150903 |
| 510k Number | K150903 |
| Device Name: | EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural |
| Classification | Needle, Acupuncture, Single Use |
| Applicant | MAANSHAN BOND MEDICAL INSTRUMENTS CO., LTD. 1358 Meishan Road, Economic & Technology Development Zone Maanshan, CN 243041 |
| Contact | Viva Gu |
| Correspondent | Kevin Walls REGULATORY INSIGHT, INC. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | MQX |
| CFR Regulation Number | 880.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-03 |
| Decision Date | 2015-07-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B33810K30302 | K150903 | 000 |
| B3385CB22402 | K150903 | 000 |
| B3385CB22502 | K150903 | 000 |
| B3385CB25252 | K150903 | 000 |
| B3385CB25402 | K150903 | 000 |
| B3385CB25502 | K150903 | 000 |
| B3385CB30302 | K150903 | 000 |
| B3385CB30402 | K150903 | 000 |
| B3385CB30502 | K150903 | 000 |
| B338AJ251002 | K150903 | 000 |
| B338AJ301252 | K150903 | 000 |
| B3385CB22252 | K150903 | 000 |
| B3385CB22132 | K150903 | 000 |
| B33810K30402 | K150903 | 000 |
| B33810K30502 | K150903 | 000 |
| B3385CB16132 | K150903 | 000 |
| B3385CB16252 | K150903 | 000 |
| B3385CB16302 | K150903 | 000 |
| B3385CB18132 | K150903 | 000 |
| B3385CB18252 | K150903 | 000 |
| B3385CB20132 | K150903 | 000 |
| B3385CB20252 | K150903 | 000 |
| B3385CB20402 | K150903 | 000 |
| B338CB35251 | K150903 | 000 |
| B338CB35402 | K150903 | 000 |
| B338CB35602 | K150903 | 000 |
| B338CJ18132 | K150903 | 000 |
| B338CJ18252 | K150903 | 000 |
| B338CJ18402 | K150903 | 000 |
| B338CJ20132 | K150903 | 000 |
| B338CJ20252 | K150903 | 000 |
| B338CJ20402 | K150903 | 000 |
| B338CJ20502 | K150903 | 000 |
| B338CJ22132 | K150903 | 000 |
| B338CJ22252 | K150903 | 000 |
| B338CJ22402 | K150903 | 000 |
| B338CJ16252 | K150903 | 000 |
| B338CJ16132 | K150903 | 000 |
| B338CB40252 | K150903 | 000 |
| B338CB40402 | K150903 | 000 |
| B338CB40502 | K150903 | 000 |
| B338CB40602 | K150903 | 000 |
| B338CB40752 | K150903 | 000 |
| B338CB50252 | K150903 | 000 |
| B338CB50402 | K150903 | 000 |
| B338CB50502 | K150903 | 000 |
| B338CB50602 | K150903 | 000 |
| B338CB50752 | K150903 | 000 |
| B338CJ22502 | K150903 | 000 |
| B3385PB14152 | K150903 | 000 |
| B3385NKJ16400 | K150903 | 000 |
| B3385NKJ18300 | K150903 | 000 |
| B3385NKJ20302 | K150903 | 000 |
| B3385NKJ22302 | K150903 | 000 |
| B3385NKJ22402 | K150903 | 000 |
| B3385NKJ25302 | K150903 | 000 |
| B3385NKJ25402 | K150903 | 000 |
| B338J18302 | K150903 | 000 |
| B338LJ3550R0 | K150903 | 000 |
| B338LJ4050R0 | K150903 | 000 |
| B3385NKJ16300 | K150903 | 000 |
| B3385PB25502 | K150903 | 000 |
| B3385PB14300 | K150903 | 000 |
| B3385PB16152 | K150903 | 000 |
| B3385PB16302 | K150903 | 000 |
| B3385PB18152 | K150903 | 000 |
| B3385PB18302 | K150903 | 000 |
| B3385PB20302 | K150903 | 000 |
| B3385PB22302 | K150903 | 000 |
| B3385PB22402 | K150903 | 000 |
| B3385PB25302 | K150903 | 000 |
| B3385PB25402 | K150903 | 000 |
| B338PB16072 | K150903 | 000 |
| B338LJ4025R2 | K150903 | 000 |
| B338LJ4040R2 | K150903 | 000 |
| B33810K20151 | K150903 | 000 |
| B33810K20301 | K150903 | 000 |
| B33810K20401 | K150903 | 000 |
| B33810K22151 | K150903 | 000 |
| B33810K22301 | K150903 | 000 |
| B33810K22402 | K150903 | 000 |
| B33810K22502 | K150903 | 000 |
| B33810K25152 | K150903 | 000 |
| B33810K25302 | K150903 | 000 |
| B33810K25402 | K150903 | 000 |
| B33810K18402 | K150903 | 000 |
| B33810K18301 | K150903 | 000 |
| B338J14152 | K150903 | 000 |
| B338J14302 | K150903 | 000 |
| B338J16302 | K150903 | 000 |
| B338J18152 | K150903 | 000 |
| B338J20302 | K150903 | 000 |
| B338J22402 | K150903 | 000 |
| B338J25502 | K150903 | 000 |
| B33810K16151 | K150903 | 000 |
| B33810K16301 | K150903 | 000 |
| B33810K18151 | K150903 | 000 |
| B33810K25502 | K150903 | 000 |
| B338CJ25132 | K150903 | 000 |
| B338P12302 | K150903 | 000 |
| B338P22152 | K150903 | 000 |
| B338P22301 | K150903 | 000 |
| B338P22402 | K150903 | 000 |
| B338P22502 | K150903 | 000 |
| B338P25301 | K150903 | 000 |
| B338P25402 | K150903 | 000 |
| B338P25502 | K150903 | 000 |
| B338P25752 | K150903 | 000 |
| B338P30401 | K150903 | 000 |
| B338P30502 | K150903 | 000 |
| B338P20401 | K150903 | 000 |
| B338P20302 | K150903 | 000 |
| B338P12402 | K150903 | 000 |
| B338P14152 | K150903 | 000 |
| B338P14302 | K150903 | 000 |
| B338P16152 | K150903 | 000 |
| B338P16302 | K150903 | 000 |
| B338P16402 | K150903 | 000 |
| B338P18152 | K150903 | 000 |
| B338P18302 | K150903 | 000 |
| B338P18402 | K150903 | 000 |
| B338P20152 | K150903 | 000 |
| B338P30751 | K150903 | 000 |
| B338PB16151 | K150903 | 000 |
| B338PB18151 | K150903 | 000 |
| B338L30302 | K150903 | 000 |
| B338L30402 | K150903 | 000 |
| B338L30502 | K150903 | 000 |
| B338L30602 | K150903 | 000 |
| B338L30752 | K150903 | 000 |
| B338Q16302 | K150903 | 000 |
| B338Q30502 | K150903 | 000 |
| B338Q30602 | K150903 | 000 |
| B338SIX20302 | K150903 | 000 |
| B338SIX25402 | K150903 | 000 |
| B338L25402 | K150903 | 000 |
| B338L25302 | K150903 | 000 |
| B338PB20151 | K150903 | 000 |
| B338PB22151 | K150903 | 000 |
| B338PTN22162 | K150903 | 000 |
| B338C16252 | K150903 | 000 |
| B338C30502 | K150903 | 000 |
| B338G16302 | K150903 | 000 |
| B338G30502 | K150903 | 000 |
| B338L16251 | K150903 | 000 |
| B338L18302 | K150903 | 000 |
| B338L20302 | K150903 | 000 |
| B338SIX30502 | K150903 | 000 |
| B338CJ25252 | K150903 | 000 |
| B338CJ35602 | K150903 | 000 |
| B338CJ35752 | K150903 | 000 |
| B338CJ401002 | K150903 | 000 |
| B338CJ401252 | K150903 | 000 |
| B338DPB16071 | K150903 | 000 |
| B338DPB16132 | K150903 | 000 |
| B338DPB18072 | K150903 | 000 |
| B338DPB20072 | K150903 | 000 |
| B338DPB20132 | K150903 | 000 |
| B338DPB22072 | K150903 | 000 |
| B338CJ351252 | K150903 | 000 |
| B338CJ351002 | K150903 | 000 |
| B338CJ25402 | K150903 | 000 |
| B338CJ25502 | K150903 | 000 |
| B338CJ25752 | K150903 | 000 |
| B338CJ301002 | K150903 | 000 |
| B338CJ30252 | K150903 | 000 |
| B338CJ30302 | K150903 | 000 |
| B338CJ30402 | K150903 | 000 |
| B338CJ30502 | K150903 | 000 |
| B338CJ30602 | K150903 | 000 |
| B338CJ30752 | K150903 | 000 |
| B338HB18081 | K150903 | 000 |
| B338IDN12052 | K150903 | 000 |
| NKJ14302 | K150903 | 000 |
| B338NKJ25152 | K150903 | 000 |
| B338NKJ25302 | K150903 | 000 |
| B338NKJ25402 | K150903 | 000 |
| B338NKJ25502 | K150903 | 000 |
| B338NKJ25752 | K150903 | 000 |
| B338NKJ30152 | K150903 | 000 |
| B338NKJ30302 | K150903 | 000 |
| B338NKJ30402 | K150903 | 000 |
| B338NKJ30502 | K150903 | 000 |
| B338NKJ30752 | K150903 | 000 |
| B338NKJ22502 | K150903 | 000 |
| B338NKJ22402 | K150903 | 000 |
| B338NKJ16152 | K150903 | 000 |
| B338NKJ16301 | K150903 | 000 |
| B338NKJ18152 | K150903 | 000 |
| B338NKJ18302 | K150903 | 000 |
| B338NKJ18402 | K150903 | 000 |
| B338NKJ20152 | K150903 | 000 |
| B338NKJ20302 | K150903 | 000 |
| B338NKJ20402 | K150903 | 000 |
| B338NKJ22152 | K150903 | 000 |
| B338NKJ22302 | K150903 | 000 |
| B338P12151 | K150903 | 000 |