(41 days)
Not Found
No
The description focuses on air pressure massage mechanics and control systems, with no mention of AI or ML.
Yes
The device is described as intended to "temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas," which are therapeutic claims.
No
The device is described as an air pressure massager intended to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation. It simulates manual kneading and stroking of tissues. There is no mention of it being used to identify, monitor, or assess a medical condition, which are typical functions of a diagnostic device.
No
The device description explicitly details hardware components such as an air compressor unit, inflatable "appliances", plastic air tubing, and an AC-DC adaptor. It also mentions being powered by an external power supply or internal battery. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the NormaTec Pulse and Pulse Pro is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas." This is a therapeutic and physical therapy-related use, not a diagnostic one.
- Device Description: The device is described as an "air pressure massager" that simulates "manual kneading and stroking of tissues." This is a physical mechanism of action, not one that involves analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for a health issue.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. The NormaTec Pulse and Pulse Pro does not fit this description.
N/A
Intended Use / Indications for Use
The NormaTec Pulse and Pulse Pro is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Product codes (comma separated list FDA assigned to the subject device)
IRP
Device Description
The NormaTec Pulse and Pulse Pro are powered inflatable tube massagers. They are intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery.
The NormaTec Pulse and Pulse Pro consist of an air compressor unit with a control system, an inflatable "appliance" (arms, legs and hips), plastic air tubing with proprietary connectors for connecting the device to the appliance; and an AC-DC adaptor with power cord.
The inflatable leg and arm "appliances", and the plastic air tubing are identical to the components of the FDA-cleared NormaTec MVP (K112890). The hip appliance is of the same general design and uses identical materials. Additionally, the air compressor, valve, valve control are similar to the predicate NormaTec MVP.
The user interface on the Pulse Pro model is a 4.3"Color TFT Screen with Capacitive Sensor (similar to a Smartphone). The user interface on the Pulse model is 4.3" Color LCD Screen, with Membrane Keypad with dome switches. There is no difference in function between the two interface technologies, they are just being offered for slight feature differences and user preferences.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Treated areas (implies where the inflatable appliance is applied: arms, legs, and hips)
Indicated Patient Age Range
Adults
Intended User / Care Setting
OTC; Clinics, hospital, athlete training, and home environments
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)
Bench testing was performed to ensure all requirements have been met, including:
- Testing of all controls
- Testing of all indicators
- Testing of battery state indicators
- Testing of performance
- Testing of hazard mitigations
The device has also been tested to the requirements of the following standards:
- AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment - part 1: general requirements for basic safety and essential performance
- IEC 60601-1-2: 2007 Collateral standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-11: 2010, Collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
No animal testing or clinical testing was performed.
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.
K112890 - NormaTec MVP, K122154 - Figg, LLC PowerPlay model PPRT-01
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
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a family of three people.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 13, 2016
NormaTec Industries, LP % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K160608
Trade/Device Name: NormaTec Pulse and NormaTec Pulse Pro Regulation Number: 21 CFR 890.5650 Regulation Name: Powered inflatable tube massager Regulatory Class: Class II Product Code: IRP Dated: March 28, 2016 Received: March 29, 2016
Dear Mr. Job:
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. 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.
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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -A
for Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160608
Device Name
NormaTec Pulse and NormaTec Pulse Pro
Indications for Use (Describe)
The NormaTec Pulse and Pulse Pro is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
| Official Address: | NormaTec Industries, LP
44 Glen Ave
Newton, MA 02459
Tel – 617 658 5827 Fax - 617 928 3407 |
|----------------------------|-----------------------------------------------------------------------------------------------------|
| Official Contact: | Peter Novello – Director Manufacturing and Regulatory |
| Proprietary or Trade Name: | NormaTec Pulse and NormaTec Pulse Pro |
| Common/Usual Name: | Powered inflatable tube massager. |
| Classification Name/Code: | IRP - Powered inflatable tube massager
Class II |
| Device Name: | NormaTec Pulse and NormaTec Pulse Pro |
| Predicate Devices: | K112890 - NormaTec MVP
K122154 - Figg, LLC PowerPlay model PPRT-01 |
Device Description:
The NormaTec Pulse and Pulse Pro are powered inflatable tube massagers. They are intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. They simulate manual kneading and stroking of tissues by use of an inflatable pressure cuff. The device is to be used by people who are in good health. The devices are powered from an external IEC 60601-1 compliant power supply and can optionally be powered by an internal lithium ion battery.
The NormaTec Pulse and Pulse Pro consist of an air compressor unit with a control system, an inflatable "appliance" (arms, legs and hips), plastic air tubing with proprietary connectors for connecting the device to the appliance; and an AC-DC adaptor with power cord.
The inflatable leg and arm "appliances", and the plastic air tubing are identical to the components of the FDA-cleared NormaTec MVP (K112890). The hip appliance is of the same general design and uses identical materials. Additionally, the air compressor, valve, valve control are similar to the predicate NormaTec MVP.
The user interface on the Pulse Pro model is a 4.3"Color TFT Screen with Capacitive Sensor (similar to a Smartphone). The user interface on the Pulse model is 4.3" Color LCD Screen, with Membrane Keypad with dome switches. There is no difference in function between the two interface technologies, they are just being offered for slight feature differences and user preferences.
4
Intended User
OTC
Patient Population Adults
Indications for Use:
The NormaTec Pulse and Pulse Pro is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Environment of Use:
Clinics, hospital, athlete training, and home environments
Contraindications:
- Do not use this product if you are experiencing inflammation, an infection, pain of . unknown origin, or bleeding (internal or external) at or near the site of application or if you have a wound at or near the site of application.
- Do not use this product if you are under the care of a physician or have a condition ● requiring the use of any medical device.
- Do not use this product on sensitive skin or on in the presence of poor circulation. ●
- Do not use this product if you have any of the following conditions: ●
- Acute pulmonary edema O
- Acute thrombophlebitis O
- Acute congestive cardiac failure 1 o
- Acute infections O
- Deep Vein Thrombosis (DVT) O
- Episodes of Pulmonary embolism о
- Wounds lesions or tumors at or in the vicinity of application O
- Where increased venous and lymphatic return is undesirable o
- о Bone fractures or dislocations at or in the vicinity of application
These contraindications are identical to the predicate.
5
Differences Between Pulse and Pulse Pro
The table below details features available on Pulse Pro that are not available on Pulse
| Characteristic | PULSE | PULSE PRO |
|---|---|---|
| Power on: The system recalls and displays the last used settings for: | X | X |
| Treatment time | X | X |
| Treatment mode | ||
| Therapy mode | X | |
| Rehab mode - recalls zone focus | ||
| Custom - recalls all settings | ||
| Recovery Flush | ||
| Appliance type | X | |
| Power level | X | X |
| Number of zones | X | X |
| Rest time | X | X |
| Brightness settings | X | |
| Time | ||
| Add time | ||
| Before treatment | X | X |
| During treatment | ||
| Decrease time | ||
| Before treatment | X | X |
| During treatment | ||
| Continuous mode | X | X |
| Counter | ||
| Count down - 1 second increments | X | X |
| Count up (continuous mode) – 1 second increments | X | |
| Compliance - Trip meter – reset by User | X | |
| Chronometer Odometer – cannot be reset by User | X | |
| Pressure | ||
| Increase level | ||
| Before treatment | X | X |
| During treatment | ||
| Decrease level | ||
| Before treatment | X | X |
| During treatment | ||
| Treatment mode – Can only be changed before treatment begins | ||
| NormaTec Pulse | X | X |
| Sequential | X | X |
| Rest Time | ||
| View or change rest time - before treatment | X | X |
| # of zones | ||
| Change number of zones - before treatment | X | X |
| Treatment | ||
| Starting | X | X |
| Pause | X | X |
| Un-pause | X | X |
| End – If timer reaches 0:00⁰⁰, treatment will continue until Rest period is | ||
| reached. The user is given options to either: | X | |
| Add time | ||
| Continue until cycle is finished | ||
| Quit | ||
| Battery charging | ||
| Displays battery level | X | X |
| Displays when battery is charging | X | X |
| Power off | ||
| No treatment in process | X | X |
| Treatment in process | X | X |
| Appliance type | ||
| Select appliance type - boot, arm, hip | ||
| Note: If hip appliance is selected, treatment mode defaults to 2-zone | ||
| treatment | X | |
| Therapy mode | ||
| Recovery flush | ||
| Preset Pulse time / Pulse pressure values | ||
| Appliance type applicable - Boot, arm, hip | X | |
| Rehab | ||
| Preset Pulse time / Pulse pressure values | ||
| Leg appliance - Foot/ankle, calf, knee, lower quad, upper quad | ||
| Arm appliance - hand/wrist, forearm, elbow, bicep, shoulder | ||
| Hip appliance - Quadriceps, hip | X | |
| Custom Settings | X | |
| Allows user to program NormaTec Pulse pressure and time | ||
| values for each zone | ||
| Pressure range - 30-100 mmHg, user can select in 10mmHg | ||
| increments | ||
| Time range - 15 seconds to 4 minutes, user can select in 15 | ||
| second increments | ||
| Display settings adjustment | ||
| Brightness controls | X |
6
7
Predicate Device Comparison:
The Pulse and Pulse Pro were compared to the predicates NormaTec MVP - K112890 and Figg PowerPlay model PPRT-01 - K122154 in the device comparison tables below.
| Model Name
510(k) Number | Subject Device K160608
NormaTec Pulse and Pulse
Pro | Predicate Device
K112890 NormaTec
MVP | Comment |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | NormaTec Industries | NormaTec Industries | Identical |
| Indications for use | The NormaTec Pulse and Pulse
Pro is an air pressure massager
intended to temporarily relieve
minor muscle aches and/or
pains, and to temporarily
increase circulation to the
treated areas. | The NormaTec MVP is an
air pressure massager
intended to temporarily
relieve minor muscle
aches and/or pains, and to
temporarily increase
circulation to the treated
areas. | Identical |
| Contraindications | Specified below | Specified below | Identical |
| Prescriptive or
OTC | OTC | OTC | Identical |
| Power Source(s) | 12 VDC via an IEC 60601-1
compliant power supply (100-
240 VAC input)
Optional Integrated
rechargeable battery | 12 VDC via an IEC
60601-1 compliant power
supply (100 - 240 VAC
input) | Pulse and Pulse Pro
have an optional
integral battery not
required for
function. |
| Software/Firmwar
e/Microprocessor
Control | Microprocessor | Analog | Software provides
identical control
functionality,
additionally
provides visual
feedback |
| Technology | Compressor and valve system
which sequentially inflates cells
of appliance | Compressor and valve
system which sequentially
inflates cells of appliance | Identical technology |
| Compliance with
Voluntary
standards | ES 60601-1, IEC 60601-1-2,
IEC 60601-1-11 | IEC 60601-1, IEC 60601-
1-2 | Pulse / Pulse Pro
complies with
currently recognized
version of 60601-1
and home use
standard |
| Device
Pressure range | 30-110 mmHg | 30 - 110 mmHg | Identical |
| Treatment Time | Stays on until the user turns it
off or can be set up to turn off
in a range of 10 mins to
continuous | Stays on until the user
turns it off | Added ability to
time treatment |
| Inflation/deflation
cycle type | Sequential Gradient, Peristaltic
and | Sequential Gradient,
Peristaltic and Pulsing | Identical |
| Appliance contact
surface material | 200 denier nylon with a
polyurethane
laminate/extrusion | 200 denier nylon with a
polyurethane
laminate/extrusion | Identical |
| Number of
Inflatable
appliance segments | 5 or less | 5 or less | Identical |
| Weight | 3.6 pounds (incl. battery) | 8 pounds | Similar |
| Dimensions (W x H
x D) | 4" x 5" x 9" | 11" x 6.5" x 7" | Similar |
| Housing Materials
and
Constructions | Molded ABS enclosure (94V0) | Thermoplastic | Similar |
| Patient contact | Non-conductive appliances | Non-conductive
appliances | Identical |
| Appliances | Leg, Arm, Hip | Leg, Arm | Leg and Arm
appliances
are identical to
510(k)
K112890.
A hip appliance is
available as part of
predicate K122154 |
| Parameter | Subject Device K160608
NormaTec Pulse and Pulse Pro | Predicate K122154
Power Play | Comment |
| Treatment Time | User controlled 10 minutes to
175 minutes or continuous -total
time over 4 segments | 20 minutes max per port
(segments) | The Pulse and Pulse
Pro allow the user to
adjust the treatment
time while the
predicate device
(K112154) time is
fixed at 20 minutes.
There is no impact to
safety or
effectiveness with
this adjustable option
and ability to select a
longer treatment time
with the hip
appliance. |
| Pressure Range | 30-110 mmHG | 30-70 mmHG | The Pulse and Pulse
Pro have a broader
pressure range than
the predicate device
(K112154) with
maximum pressure of |
8
9
appliances.
| 510(k) Summary | |||
|---|---|---|---|
| 110mmHG. This | |||
| pressure is the same | |||
| maximum used on | |||
| the Pulse and Pulse | |||
| Pro Arm and Leg | |||
| appliances (and | |||
| predicate NormaTec | |||
| MVP 510(k) | |||
| K112890). As the hip | |||
| area is a larger body | |||
| mass than the arm | |||
| and leg appendages, | |||
| this higher pressure | |||
| presents no | |||
| compromises to | |||
| safety or | |||
| effectiveness to the | |||
| user wearing the hip | |||
| appliance. | |||
| Inflation Cycle / | |||
| Pulsing | Preinflate ,then either sequential | ||
| or peristaltic Pulsing as selected | |||
| by user | |||
| -with adjustable rest time | Preinflate, rest, deflate then | ||
| repeat the sequencing | The Pulse and Pulse | ||
| Pro have 2 different | |||
| massage patterns that | |||
| can be selected by the | |||
| user as well as having | |||
| the option to adjust | |||
| the rest time. The | |||
| predicate device | |||
| (K112154) has a | |||
| predetermined cycle | |||
| and rest-time. There | |||
| is no impact of safety | |||
| or effectiveness with | |||
| the differences in the | |||
| massage patterns | |||
| between the | |||
| NormaTec and the | |||
| predicate's hip |
510(k) Summary
10
Performance Testing
Bench:
The device has been tested to ensure that it all requirements have been met, this includes:
- Testing of all controls ●
- Testing of all indicators
- Testing of battery state indicators
- Testing of performance
- . Testing of hazard mitigations
The device has also been tested to the requirements of the following standards:
AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment - part 1: ● general requirements for basic safety and essential performance
IEC 60601-1-2: 2007 Collateral standard: Electromagnetic Compatibility - Requirements ● and Tests
IEC 60601-1-11: 2010, Collateral standard: requirements for medical electrical ● equipment and medical electrical systems used in the home healthcare environment
Animal:
No animal testing was performed
Clinical:
No clinical testing was performed
Conclusion
The NormaTec Pulse and Pulse Pro are substantially equivalent to the predicates in: indications for use, contraindications, patient population, environment of use, technology characteristics, materials, specifications / performance and compliance with international standards. Minor differences as detailed in the substantial equivalence table above do not raise questions of safety and effectiveness.