Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

• K Number: K182136
• Device Name: Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
• Manufacturer: Shenzhen OSTO Technology Co., Ltd.
• Date Cleared: 2019-10-10 ( 430 days)
• Product Code: NUH NGX
• Regulation Number: 882.5890

Intended Use

Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs.

Device Description

Intelligent Wireless Fitness Apparatus is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. By muscle stimulation, the device helps to strengthen and firm the abdomen, arms and thighs. The device is including a main unit and 3 kinds of electrode pads. The therapeutic parameters are easily set using the buttons on the device. There are three buttons on the main unit, On/off button for on/off and mode selection, "+" button and "-" button for level adjustment. The accessories is electrode pads. The electrode pads connect to the main unit by buttons (which is permanent secured on the main unit and the electrode pad). All the accessories can only be changed by local distributor.

Predicate Devices

K131291, K133929

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a muscle stimulator with basic controls and no mention of adaptive algorithms, data processing, or AI/ML specific terms. The "Intelligent" in the name appears to be a marketing term.

Therapeutic

Yes
The device strengthens, tones, and firms muscles, which are therapeutic effects for the body.

Diagnostic

No
The device's intended use and function are described as strengthening, toning, and firming muscles through electrical stimulation, indicating a therapeutic rather than a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it includes a "main unit" and "electrode pads," which are hardware components. The summary also mentions electrical safety, electromagnetic compatibility, and battery standards testing, all related to hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for improving muscle tone, strengthening, and firming abdominal muscles, buttocks, and thighs through muscle stimulation. This is a physical effect on the body, not a diagnostic test performed on samples taken from the body.
• Device Description: The device description details a physical apparatus that applies muscle stimulation. It does not mention any components or processes related to analyzing biological samples.
• Performance Studies: The performance studies focus on electrical safety, electromagnetic compatibility, usability, software verification, and biocompatibility of materials. These are typical evaluations for devices that interact physically with the body, not for IVDs which analyze samples.
• Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There is no mention of detecting or measuring substances within these samples for diagnostic purposes.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Intelligent Wireless Fitness Apparatus is indicated to be used for:

Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs.

Product codes (comma separated list FDA assigned to the subject device)

NGX

Device Description

Intelligent Wireless Fitness Apparatus is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. By muscle stimulation, the device helps to strengthen and firm the abdomen, arms and thighs.

The device is including a main unit and 3 kinds of electrode pads. The therapeutic parameters are easily set using the buttons on the device.

There are three buttons on the main unit, On/off button for on/off and mode selection, "+" button and "-" button for level adjustment.

The accessories is electrode pads. The electrode pads connect to the main unit by buttons (which is permanent secured on the main unit and the electrode pad). All the accessories can only be changed by local distributor.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

abdominal muscles, buttocks and thighs

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Intelligent Wireless Fitness Apparatus, Model: AST-301, AST-302, AST-303 had been evaluated the safety and performance by lab bench testing as following:

• Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards
• Electromagnetic compatibility test according to IEC 60601-1-2 standard
• Usability test according to IEC 62366 standard
• Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
• IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]

The materials and manufacturing used for the Intelligent Wireless Fitness Apparatus are identical to those of the predicate device K133929, and the Electrode Pads have been demonstrated to conform with the following biocompatibility standards:

• ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity
• ISO 10993-10: 2009, Biological evaluation of medical devices - Part 10: Tests for irritation and delayedtype hypersensitivity

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K131291, K133929

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 10, 2019

Shenzhen OSTO Technology Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou. 510663 CN

Re: K182136

Trade/Device Name: Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-303) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: September 10, 2019 Received: September 13, 2019

Dear Cassie Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

For Vivek Pinto. PhD Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182136

Device Name Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)

Indications for Use (Describe)

Intelligent Wireless Fitness Apparatus is indicated to be used for:

Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. Strengthening, Toning and Firming of buttocks and thighs.

Type of Use (Select one or both, as applicable)

|--|--|

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: Shenzhen OSTO Technology Co., Ltd. Establishment Registration Number: Applying Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District, Shenzhen City Guangdong Province, CHINA Tel: [phone] Fax: [phone] Contact Person: Li Yang (General Manager) Email: [e-mail]

Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Tel: [phone] Email: [e-mail]

2. Subject Device Information

Company Name: Shenzhen OSTO Technology Co., Ltd. Trade/Device Name: Intelligent Wireless Fitness Apparatus Model Name: AST-301, AST-302, AST-303 Common Name: Powered Muscle Stimulator Product Code: NGX Regulation Number: 21 CFR 890.5850 Regulatory Class: 2

3. Predicate Device Information

Predicate Device 1:

510(K) Number: K131291 Company Name: Johari Digital HealthCare Ltd. Trade/Device Name: Torc Body Common Name: Powered Muscle Stimulator Product Code: NGX Regulation Number: 21 CFR 890.5850 Regulatory Class: 2

Predicate Device 2:

510(K) Number: K133929 Company Name: Shenzhen OSTO Technology Co., Ltd. Trade Device Name: Health Expert Electronic Stimulator Common Name: Electronic Stimulator Product Code: NUH, NGX Regulation Number: 882.5890, 890.5850 Regulatory Class: 2

4. Device Description

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Intelligent Wireless Fitness Apparatus is indicated to be used for: Improvement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. By muscle stimulation, the device helps to strengthen and firm the abdomen, arms and thighs.

The device is including a main unit and 3 kinds of electrode pads. The therapeutic parameters are easily set using the buttons on the device.

There are three buttons on the main unit, On/off button for on/off and mode selection, "+" button and "-" button for level adjustment.

The accessories is electrode pads. The electrode pads connect to the main unit by buttons (which is permanent secured on the main unit and the electrode pad). All the accessories can only be changed by local distributor.

5. Intended Use / Indications for Use

Intelligent Wireless Fitness Apparatus is indicated to be used for:

lmprovement of abdominal tone, strengthening of the abdominal muscles development of firmer abdomen. Strengthening, toning and firming of buttocks and thighs.

6. Test Summary

Intelligent Wireless Fitness Apparatus, Model: AST-301, AST-302, AST-303 had been evaluated the safety and performance by lab bench testing as following:

• Electrical safety test according to IEC 60601-1, IEC 60601-1-11 and IEC 60601-2-10 standards �
• � Electromagnetic compatibility test according to IEC 60601-1-2 standard
• � Usability test according to IEC 62366 standard
• � Software verification and validation test according to the requirements of the FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
• � IEC 62133 Edition 2.0 2012-12 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]

Note:

The materials and manufacturing used for the Intelligent Wireless Fitness Apparatus are identical to those of the predicate device K133929, and the Electrode Pads have been demonstrated to conform with the following biocompatibility standards:

• ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity

• ISO 10993-10: 2009, Biological evaluation of medical devices - Part 10: Tests for irritation and delayedtype hypersensitivity

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of Intelligent Wireless Fitness Apparatus is substantially equivalent to the predicate devices quoted above. The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of

Comparison	Subject Device	Predicate Device	Predicate Device	Remark
510(k) number	Applying	K131291	K133929	--
Device name	Intelligent Wireless
Fitness Apparatus	Torc Body	Health Expert
Electronic Stimulator	--
Model Name:	AST-301, AST-302,	--	AST-300C and AST-	--

5

		AST-303		300D
Company name		Shenzhen OSTO
Technology Co., Ltd.	Johari Digital
HealthCare Ltd	Shenzhen OSTO
Technology Co., Ltd.
Product Code		NGX	NGX	NUH, NGX	SE
Regulation Number		21 CFR 890.5850	21 CFR 890.5850	882.5890, 890.5850	SE
Indications for
Use		Intelligent Wireless
Fitness Apparatus is
indicated to be used
for:
Improvement of
abdominal tone,
strengthening of the
abdominal muscles
development of
firmer abdomen.
Strengthening, toning
and firming of
buttocks and thighs.	Torc Body is
indicated to be used
for:
Improvement of
abdominal tone, for
strengthening of the
abdominal muscles,
for development of
firmer abdomen.
Strengthening,
Toning and Firming
of buttocks & thighs.	PMS (Mode 1~8) It is
intended to stimulate
healthy muscles in
order to improve and
facilitate muscle
performance. TENS
(Mode 9~25) To be
used for temporary
relief of pain
associated with sore
and aching muscles in
the shoulder, waist,
back, back of the
neck, arm, leg, and
foot due to strain from
exercise or normal
household work
activities by applying
current to stimulate
nerve.	SE
Primary Function		Muscle stimulation	Muscle stimulation	Muscle stimulation	SE
Principle of
Action		Initiating action
potential of nerves
results in muscle
contraction	Initiating action
potential of nerves
results in muscle
contraction	Initiating action
potential of nerves
results in muscle
contraction	SE
Clinical Use		OTC	OTC	OTC	SE
Target area		abdominal muscles,
buttocks and thighs	abdominal muscles,
buttocks and thighs	abdominal muscles,
buttocks thighs and
foot	SE
Shape of electrode		Butterfly-shaped,
irregular	Butterfly-shaped,
irregular	Rectangle, irregular	SE
Method of electrode
application		Self-adhesive with
belt versus adhesive
silicone	Self-adhesive with
belt versus adhesive
silicone	Self-adhesive with
belt versus adhesive
silicone, non-adhesive	SE
Power Source(s)		Adapter (Model
HDMU05E-050100,
HDMU05B-050100,
HDMU05U-050100 )
Input:100-240 Vac;
50/60 Hz; 0,3A;
Output: 5 V ; 1A
Rechargeable
Lithium-ion Battery:
3.7Vdc	24 V DC Battery
pack	100 - 240 V AC, 50-
60 Hz	SE
Note 2
Electrical Protection		Class II, BF	Class II, BF	Class II, BF	SE
-Method of Line
Current Isolation		Type BF Applied Part	Type BF Applied Part	Type BF Applied Part	SE
Patient
Leakage	NC	$\leq$ 0.1 $\mu$ A	--	--	SE
Current
Number of Output
Modes		8	2	25	SE
Note 1
Number of Output
Channels:		2	--	2	SE
Synchronous or
Alternating		Alternating	--	Alternating	SE
Method of Channel
Isolation		Voltage Transform
Isolation	--	Voltage Transform
Isolation	SE
Regulated Current or
Regulated Voltage		Voltage Control	Voltage Control	Voltage Control	SE
Software/Firmware/M
icroprocessor
Control		Yes	Yes	Yes	SE
Automatic Overload
Trip		No	No	No	SE
Automatic No-Load
Trip		No	No	No	SE
Automatic Shut Off		Yes	--	Yes	SE
Patient Override
Control		Yes	Yes	Yes	SE
	On/Off
Status	Yes	--	Yes	SE
Indicator
Display	Low
Battery	Yes	--	No	SE
	Voltage/
Current
Level	Yes		Yes	SE
Timer Range
(minutes) (clarify for
each mode if
different)		15min	1- 60 min	25min	SE
Note1
Compliance with
Voluntary Standards		Complied with
ISO 10993-5,
ISO 10993-10,
IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-10	Complied with
ISO 10993-5,
ISO 10993-10,
IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-10	Complied with
ISO 10993-5,
ISO 10993-10,
IEC 60601-1,
IEC 60601-1-2,
IEC 60601-2-10	SE
	Weight		80g (Without
accessories)	--	2Kg (Without
accessories)	SE
Note1
	Housing Materials
and Construction		Main unit: ABS
plastic	--	Main unit: ABS plastic	SE
	Waveform (e.g.,
pulsed monophasic,
biphasic)		Pulsed, symmetric,
biphasic	--	Pulsed, symmetric,
biphasic	SE
	Maximum Output
Voltage		44V±10% @ 500Ω
80V±10% @ 2ΚΩ
112V±10% @ 10ΚΩ	--	44V±10% @ 500Ω
80V±10% @ 2ΚΩ
112V±10% @ 10ΚΩ	SE
Maximum Output
Current		88mA±10% @ 500Ω
40mA±10% @ 2ΚΩ
11.2mA±10%
@10ΚΩ	--	88mA±10% @ 500Ω
40mA±10% @ 2ΚΩ
11.2mA±10% @10ΚΩ	SE
	For multiphasic
waveforms only: -		Symmetrical phases	--	Symmetrical phases	SE
Symmetrical phases
Phase Duration		$120 \mu s$	$290 \mu s$	$120 \mu s$	SE
Net Charge (mC per pulse)		$10.56 \mu C @ 500\Omega$	--	$10.56 \mu C @ 500\Omega$	SE
Maximum Phase Charge, (mC)		$12.78 \mu C @ 500\Omega$	$35.7 \mu C @ 500\Omega$	$12.78 \mu C @ 500\Omega$	SE
Maximum Average Current		$1.69mA @ 500\Omega$	--	$1.69mA @ 500\Omega$	SE
Maximum Current Density, (mA/cm²)		$0.026mA/cm^2 @ 500\Omega$	$0.176mA/cm^2$	$0.026mA/cm^2 @ 500\Omega$	SE
Maximum Power Density		$16.37 \mu W/cm^2 @ 500\Omega$	$0.0089 W/cm^2$	$16.37 \mu W/cm^2 @ 500\Omega$	SE
Burst Mode (i.e., pulse trains)	Pulses per burst	1	--	1	SE
	Bursts per second	77	--	77	SE
	Burst duration (seconds)	12.94ms	--	12.94ms	SE
	Duty Cycle [Line (b) x Line (c)	$240 \mu s/12.94ms$	--	$240 \mu s/12.94ms$	SE
ON Time (seconds)		3s	--	3s	SE
OFF Time (seconds)		3s	--	3s	SE
Type of Energy		Electrical	Electrical	Electrical	SE
Type of Operation		Continuous	Continuous	Continuous	SE
Pulse Repetition Rate		8.33 Hz	1 – 200 Hz	8.33 Hz	SE
Pulse Amplitude		0 – 100%	0 – 100%	0 – 100%	SE
Induced Current in the Tissue		11.2-80 mA	28 mA	11.2-80 mA	SE
Selection of parameters (Intensity)		Yes	Yes	Yes	SE
Shape of Stimulation Pulse		Rectangular, with interphase interval	Symmetrical Biphasic Square Wave	Rectangular, with interphase interval	SE
Energy Source		Adapter (Model HDMU05E-050100, HDMU05B-050100, HDMU05U-050100 ) Input: 100-240 Vac; 50/60 Hz; 0,3A; Output: 5 V ; 1A Rechargeable Lithium-ion Battery: 3.7Vdc	24 V DC Battery pack and Adaptor: 100 – 240 V AC, 50–60 Hz	Adaptor Input: 100-240Vac, 50-60Hz, 0.1A Output: 5Vdc, 1A Unit Input: 5Vdc, 1A	SE Note 2
System Dimensions		Main Unit: 50X37mm	Main Unit: 152x102x203 mm	428 x428.8 x 185mm	SE Note1
	model AST-301:
198mm x 164mm x
2mm
Electrode pad for
model AST-302:
192mm x 164mm x
2mm
Electrode pad for
model AST-303: 125
mm x 80mm x 2mm
Each gel sheet
90mm x 60mm x2
mm	Electrodes:
Large (50mm)
Small
(40mmx80mm)	Electrodes:
Foot Conductive
Rubber: 254mm x
98mm x 13mm,
99.27 cm2
Small: 88mm x 58mm
x 3.2mm,
50.04 cm2
Electrode materials	Transparent PET
silicone (Gel sheet)	--	Small Electrode Pads:
white silica gel, black
conductive silicone,
transparent
conductive adhesive
silicone, transparent
PET silicone	SE
Ambient
Temperature		0°C to +44°C	5°C to +45°C	SE
Note 1
Environmental
Specifications	For indoor use only	For indoor use only	For indoor use only	SE

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Note 1:

Although the "Number of Output Modes", "Time Range", "Indicator Display", "Ambient Temperature", "Dimensions" and ""weight" are a little difference from the predicate devices, but these are not key parameters which affect safety or effectiveness, so the differences will not raise any safety or effectiveness issue.

Note 2:

Although the "Power Source" and "Energy Source" of subject device are different from predicate devices, but it all comply with IEC 60601-1 and IEC 60601-2-10 requirements, so the differences will not raise any safety or effectiveness issue.

Finial Conclusion:

The subject device "Intelligent Wireless Fitness Apparatus model AST-301, AST-302, AST-303" is Substantial Equivalent to the predicate devices K131291 and K133929.

8. Date of the summary prepared: October 9, 2019