(4 DEPARTMENT OF HEALTH & HUMAN SERVICES PublicHeal叫 Ser.

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FoodandDrugAdmihistration
10903NewHpmpshiGc Avenue
Document CohtrolRdom-W066-G609
SilverSprinιIMD20993- 02 ∞

Avita (Wujiang) CO.， LTD

c/o: Ms. Jennifer Reich JAN 1 8 2012
Harvest Consulting Co叩(USA)
2904 N. Boldt Drive
Flagstaff ，
AZ 86001

Re: KI12825
Trade Name: Avita m type blood pressure monitor
訂

Regulation Number: 21 CFR 870.1130

Regulation Name: Noninvasive blood pressure measurement system
Regulatory Class: II (two)
Product Code: DXN (N oninvasive blood pressure measurement system) 。
Dated: 12115120II
Received: 12/16/2011

Dear Mr
s. Reich:

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commerce prior to May 訝， 1976 ，the enactment date of the Medical Device Amendment~ ，or 的
d 肝 l臼 s that have been reclassified in accordance with 出 e provisions of the Fede 叫 Food) Drug ，
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)
Youm 旬，therefore ，market the devi 侃，subject to the general controls provisions of the Apt. The
general controls provisions of the Act include req re叩開 ts for annual registration ，listin g!
山 of
devices ，good manufacturing practice ，labeling ，and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liabili
warranties. We remind you ， however ， that device labeling must be truthful and not misle~ding.

If your device is classified (see above) into either class II (Special Controls) or cl 的 s III (PMA) ，it
may be subj 民 t to additional controls. Existing major regulations affecting your device cap be
found in the Code of Fede I Regulations ，Title 21 ，Parts 800 to 898. In addition ，FDA m~y
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publish further announcements concerning your device in the Federal Registe r.

Page 2 - Ms. Jennifer Reich

Please be advised that FDA's issuance of a substantial equivalence determination does 恥 t m~an
that FDA has made a determination that your device complies with other requirements </fthe ~ct
or any Federal statutes and regulations administered by other Federal agencies. You m t\ st I
comply with all the A 仗's require 闊的，肌 lu 吋Id
刮I
呵r
CFRP 副 8ω07η);labeling (21 CFR Part 801); medical device reporting (reporting of med(cal
device-related adverse events) (21 CFR 803); good manufacturing practice requirement~ as se
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable ，the e地tronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050

If you desire specific advice for your devi 的 on our labeling regulation (21 CFR Part 801趴 pI凹se
go toh 前口。//www.fda. !l.ov/AboutFD Al CentersOffices/CD RHl CDRHO 位ices/ucmI15809. !h tm for
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Als 申， pIe河se
note the regulation entitled ，"Misbranding by reference to prem 缸ket notification" (21 CF F.Part
807.97). For questions regarding the reporting of adverse events under the MDR regulatjon (21
CFRP t 803) ，
訂 please go to
http://www.fda. !l.
ovlM edicaIDevices/Safetv lR eportaProblem/defaul t.htm for the CDRH's Office
of Surveillance and Biometrics lD ivision of Postmarket Surveillance

You may obtain other general information on your responsibilities under the Act from th
Division of Small Manufacturers ，International and Consumer Assistance at its toll-fre numbd
治

(800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda. !l.
ovlMedicaIDevices lR esourcesforYo ulI ndustrv/defaul t.
htm

Bram D. Zuckerman ， M.D

-for Director
Division of Cardiovascular Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure
 Indications for Use
K/IZ f?
G~

Device Name: AViTA BPM6x Series Arm Type Blood Pressu 間e

Monitor
AViTA Corporation

Indications for Use:

The AViTA BPM6x Series Arm Type Blood Pressure Monitor is a device intended to
measure t 悸 systolic and diastolic blood pressure and pulse rate of an adljlt I
individual by using a non-invasive oscillometric technique in which an infla~ablelcuff
is wrapped around the upper arm. The cuff circumference is limited to 2~9 mm
-330 mm (approx.: 9 - 13 inches).

The device is intended for home use. When the device detects irregular
hea 巾 eats during measu 悶悶叭 an irregular hea 吋巾bea刮t sym
帥 bol will appear叫la
訓Ion
WI此th the measured readings.

PrescriptionUse 一一-一一一 AND/OR Over-The-CounterUse V

(Part21 CFR801 Subpart
D) (21 CFR807 Subpart
C)

(PLE竺 E DO NOT WRITE 阻 O

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Concur仟rence of CDRH，0旬ce of Device Evaluation(ODE)

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