(119 days)
No
The description focuses on standard electromechanical components, firmware for control, and Bluetooth communication with a smartphone app for parameter management. There is no mention of AI/ML algorithms for data analysis, pattern recognition, or adaptive control.
Yes
The device is intended for temporary relief of minor muscle aches and pains and temporary increase in circulation, which are therapeutic claims.
No
The device description and intended use state that it is an air compression therapy device for temporary relief of muscle aches and pains and increased circulation. It does not mention any function for diagnosing conditions.
No
The device description explicitly details hardware components such as a console, compressor, valves, power adapter, battery, and prong plug, in addition to the software.
Based on the provided information, the RecoveryAir PRO is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "air compression therapy" to provide "graduated pressure to compression garments" for "temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in good health." This describes a physical therapy or rehabilitation device, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a system involving a console, compressor, valves, and compression garments. This aligns with a mechanical or pneumatic device for external application to the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro examination.
Therefore, the RecoveryAir PRO falls under the category of a physical medicine or rehabilitation device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The RecoveryAir PRO is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in good health. The RecoveryAir PRO simulates kneading and stroking of tissues by using an inflatable garment.
Product codes
IRP
Device Description
The RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The RecoveryAir PRO is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. The RecoveryAir PRO simulates kneading and stroking of tissues by using an inflatable garment.
The Console (Pressure control unit) supplies air at a regulated pressure to a compression garment worn over the area to be treated. The console contains a compressor which generates the air pressure, valves which control the outlet air, user control panel and firmware which controls the pressure and treatment cycle. The pressure control unit is powered by external DC Power Adapter, plugged into a wall electrical outlet or by a rechargeable battery which can operate the device for more than four hours. The battery is located inside the Console and can be charged while the device operates from a wall electrical outlet.
The Prong Plug is used as a dummy hose plug for sealing the second air outlet to prevent air escape when the other outlet is connected to the pressure garment.
The Medical grade DC Power Adapter, which is supplied with the device, is powered from the wall electrical outlet (100-240 VAC, 50-60 Hz) and supplies 12 VDC 3A to the Console. The DC power adaptor is also used for charging the Battery.
The Battery Pack is located inside the Console's enclosure is used as backup power. When Battery is fully charged it can power the Console for more than four (4) hours.
The Battery may be charged during normal operation of the console.
The Battery charging time is up to 8 hours.
Smart-phone application uses low power Bluetooth wireless to communicate with the Console. The application enables modifying, storage and display of the device's treatment parameters, and start/stop treatment via Bluetooth communication, similar to reference device (K190493).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
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
Electrical safety and electromagnetic compatibility (EMC) RecoveryAir PRO passed all electrical safety and EMC tests.
Electrical Safety Testing was conducted in accordance with: IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 (or IEC 60601-1:2012 reprint) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-11:2015, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home health care environment.
IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications Part 2: Lithium systems ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence.
EMC Testing was conducted in accordance with:
IEC / EN 60601-1-2:2014-02. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility.
Sterilization & Shelf-life Testing
RecoveryAir PRO is not sterile, therefore sterilization testing was not necessary to demonstrate the safety or performance of the device. The subject device has a shelf-life of 3 years.
Biocompatibility Testing
Cytotoxicity, Irritation and Sensitization testing was conducted to demonstrate the biocompatibility of the patient-contacting materials of RecoveryAir PRO, in accordance with ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity and ISO 10993-10:2010, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization.
Software Verification and Validation Testing
Software Verification and Validation Testing was conducted in accordance with IEC 62304:2006 Medical Device Software – Software Life Cycle Processes.
Animal Study: Animal testing was not required to demonstrate safety and effectiveness of RecoveryAir PRO.
Clinical Studies: Clinical testing was not required to demonstrate the safety and effectiveness of the RecoveryAir PRO.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/0 description: The image shows 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 4, 2021
Theragun, Inc. % Thomas Padula VP Regulatory Compliance Schiff & Company, Inc. 583 Mountain Avenue North Caldwell, New Jersey 07006
Re: K211745
Trade/Device Name: RecoveryAir PRO Regulation Number: 21 CFR 890.5650 Regulation Name: Powered Inflatable Tube Massager Regulatory Class: Class II Product Code: IRP Dated: September 15, 2021 Received: September 16, 2021
Dear Thomas Padula:
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/cdrl/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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211745
Device Name Recovery Air PRO
Indications for Use (Describe)
The RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The RecoveryAir PRO is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in circulation to the treated areas in good health. The RecoveryAir PRO simulates kneading and stroking of tissues by using an inflatable garment.
Type of Use (Select one or both, as applicable)
Residential Use For 26 CFR 468A(a) Claims Purposes | |
---|---|
Cost-Plus Compensation For 26 CFR 468A(a) Claims Purposes |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary (as required by 807.92)
1) SUBMITTER:
THERAGUN, Inc. 6100 Wilshire Blvd Suite 200 Los Angeles, CA 90048 Registration Number: 3012386142 FEI Number: 3012386142 Contact person: CJ Frederick, III (Director, Regulatory Compliance) Telephone: 310-570-8341 Email: cj.frederick@therabodycorp.com Date prepared: September 13, 2021
Application Correspondent:
Contact Person: Thomas Padula Company: Schiff & Company, Inc. Address: 583 Mountain Avenue, North Caldwell, NJ 07006 Tel: 201-317-8810 Email: thomaspadula@schiffandcompany.com
-
- DEVICE NAME:
Trade Name: RecoveryAir PRO Common Name: Powered inflatable tube massager Classification Name: Powered inflatable tube massager Device Classification: Class II Review Panel: Neuromodulation and Physical Medicine Devices (DHT5B) Regulation Number: 21 CFR 890.5650 Product Code: IRP
- DEVICE NAME:
-
- PREDICATE DEVICE(S): Substantial equivalence is based on following legally marketed devices.
Items | Primary Predicate Device | Reference Device |
---|---|---|
Sponsor | Mego Afek AC Ltd | Mego Afek AC Ltd |
Device Name and Model | Recovery Pump 737R | Recovery Pump 737R (RPX) |
510(k) Number | K140519 | K190493 |
Product Code | IRP | IRP |
Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5650 |
Regulation Class | II | II |
4
4) DESCRIPTION OF THE DEVICE:
The RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The RecoveryAir PRO is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. The RecoveryAir PRO simulates kneading and stroking of tissues by using an inflatable garment.
The Console (Pressure control unit) supplies air at a regulated pressure to a compression garment worn over the area to be treated. The console contains a compressor which generates the air pressure, valves which control the outlet air, user control panel and firmware which controls the pressure and treatment cycle. The pressure control unit is powered by external DC Power Adapter, plugged into a wall electrical outlet or by a recharqeable battery which can operate the device for more than four hours. The battery is located inside the Console and can be charged while the device operates from a wall electrical outlet.
The Prong Plug is used as a dummy hose plug for sealing the second air outlet to prevent air escape when the other outlet is connected to the pressure garment.
The Medical grade DC Power Adapter, which is supplied with the device, is powered from the wall electrical outlet (100-240 VAC, 50-60 Hz) and supplies 12 VDC 3A to the Console. The DC power adaptor is also used for charging the Battery.
The Battery Pack is located inside the Console's enclosure is used as backup power. When Battery is fully charged it can power the Console for more than four (4) hours.
The Battery may be charged during normal operation of the console.
The Battery charging time is up to 8 hours.
Smart-phone application uses low power Bluetooth wireless to communicate with the Console. The application enables modifying, storage and display of the device's treatment parameters, and start/stop treatment via Bluetooth communication, similar to reference device (K190493).
5) INDICATIONS FOR USE:
The RecoveryAir PRO is an air compression therapy device intended to provide graduated pressure to compression garments. The RecoveryAir PRO is indicated for
5
the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. The RecoveryAir PRO simulates kneading and stroking of tissues by using an inflatable garment.
- COMPARISON WITH PREDICATE DEVICES: Following table is a comparison of 6) RecoveryAir PRO and the predicate devices.
RecoveryAir PRO is substantially equivalent in terms of the technological characteristics, features, specifications, materials, mode of operation and indications for use, and is substantially equivalent to the predicate device quoted below. The differences between the subject device and predicate device do not raise new issues of safety or effectiveness.
6
Comparison in Detail(s):
| Elements of
comparison | Subject Device | Primary Predicate Device | Verdict |
---|---|---|---|
Manufacturer | Theragun Inc | Mego Afek AC Ltd | -- |
510K number | Subject device | K140519 | -- |
Product Name | RecoveryAir PRO (Model RecoveryAir PRO) | Recovery Pump 737R | -- |
Classification Name | Powered inflatable tube massager | Powered inflatable tube massager | same |
Regulation Class | 2 | 2 | same |
Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5650 | same |
OTC & Rx | OTC | OTC | same |
Indications for Use | The RecoveryAir PRO is an air compression therapy device | ||
intended to provide graduated pressure to compression | |||
garments. | |||
The RecoveryAir PRO is indicated for the temporary relief of | |||
minor muscle aches and pains, and for temporary increase in | |||
blood circulation to the treated areas in people who are in good | |||
health. | |||
The RecoveryAir PRO simulates kneading and stroking of | |||
tissues by using an inflatable garment. | The Recovery Pump 737R is an air | ||
compression therapy device | |||
intended to provide graduated | |||
pressure to compression garments. | |||
The Recovery Pump 737R is | |||
indicated for the temporary relief of | |||
minor muscle aches and pains, and | |||
for temporary increase in blood | |||
circulation to the treated areas in | |||
people who are in good health. | |||
The Recovery Pump 737R | |||
simulates kneading and stroking of | |||
tissues by using an inflatable | |||
garment. | same |
7
Device design | |||
---|---|---|---|
Power Source | 100-240 V AC, 50/60 Hz, 12 V or internal battery. | Not publicly available | - |
Dimensions | |||
(WHL) | 8.6in (L) *6.7in (W) *5.1in (H) | Not publicly available | - |
Weight | 4.202 pounds | Not publicly available | - |
Housing Materials | Molded ABS enclosure | Not publicly available | - |
Sleeves | RecoveryAir Compression Boots: 95*28.7 cm | Not publicly available | - |
Number of | |||
Chambers | 4-chamber | Not publicly available | - |
Sleeve Materials | Polyether Nylon Fabric | Not publicly available | - |
Modes ((Inflation | |||
sequences) | Sequential, ISO or Rehab (wave), Flow cycles | ||
Sequential mode that applies a directional massage, starting at | |||
the base of the treated area, and progresses upwards towards | |||
the torso and then releases | |||
ISO mode that applies a directional massage to a smaller, user- | |||
selected area. The first chamber inflates, and after a few | |||
seconds, the second chamber starts to inflate until both | |||
chambers reach the set pressure. Then both chambers deflate, | |||
and after a pause the process starts again | |||
Wave mode: The first chamber inflates, and after a few seconds, | Not publicly available |
8
| the 1st and 2nd chamber starts to inflate until both chambers
reach the set pressure. Then the deflation on 1st chamber , the
2nd and 3rd chambers starts to inflate until the both chambers
reach the set pressure; then deflate the 2nd chambers inflate 3rd
and 4th chambers until the both chambers reach the set pressure |
---|
Flow cycles |
Progress 1: first inflate Chamber 1 to target pressure, then hold |
& release. then go to Progress 2. |
Progress 2: first inflated Chamber 1 to target pressure, then |
inflate Chamber 2 and hold Chamber 1. when Chamber 2 reach |
the target pressure, hold chamber 1 & 2 for specified time, then |
release totally, then go to Progress 3 |
Progress 3: first inflated Chamber 1 to target pressure, then |
inflate Chamber 2 and hold Chamber 1. when Chamber 2 reach |
the target pressure, hold chamber 1 & 2, & start to inflate |
Chamber 3, when Chamber 3 reach to the target pressure, then |
hold chamber 1, 2, 3 for specified time then release totally. then |
go to Progress 4 |
Progress 4: first inflated Chamber 1 to target pressure, then |
inflate Chamber 2 and hold Chamber 1. when Chamber 2 reach |
the target pressure, hold chamber 1 & 2, & start to inflate |
Chamber 3, when Chamber 3 reach to the target pressure, then |
hold chamber 1, 2, 3,& start to inflate Chamber 4, when |
Chamber 4 reach to the target pressure, then hold chamber 1, 2, |
3 &4 for specified time then release totally. then go back to |
Progress 1 again. |
9
Image /page/9/Figure/1 description: The image shows different modes of operation, including sequential rehab (wave), wave cycle mode, and ISO cycle mode. The sequential rehab mode shows a sequence of chambers inflating and deflating in a wave-like pattern. The wave cycle mode shows a similar pattern, but with a different timing. The ISO cycle mode shows a sequence of chambers inflating and deflating in a specific order, with chambers 1 & 2 (distal), chambers 2 & 3 (mid), and chambers 3 & 4 (proximal).
10
Flow cycles | |||||
---|---|---|---|---|---|
Flow cycle mode | |||||
Chamber 1 | Chamber 2 | Chamber 3 | Chamber 4 | ||
Image: Chamber 1 flow cycle | Image: Chamber 2 flow cycle | Image: Chamber 3 flow cycle | Image: Chamber 4 flow cycle | ||
Device Pressure range | 20-100mmHg | Not publicly available | |||
Treatment Time | 10min-90min, step of 5min | Not publicly available | - | ||
Hold time within cycle | 2 - 10 sec. | Not publicly available | - |
11
| Pause interval -
between cycles | 10 - 70 Sec. | Not publicly available | - |
---|---|---|---|
Mobile application | Bluetooth communication | Not publicly available | - |
Patient contact | Non-conductive appliances | Not publicly available | - |
Software/Firmware/ | |||
Microprocessor | |||
Control | Microprocessor | Not publicly available | - |
Technology | Compressor and valve system which sequentially inflates cells | ||
of appliance | Not publicly available | - | |
FDA-Recognized Standards | - | ||
Electrical safety | |||
EMC | IEC 60601-1 | ||
IEC 60601-1-2 | |||
IEC 60601-1-11 | Not publicly available | - | |
Biocompatibility | ISO 10993-5 | ||
ISO 10993-10 | Not publicly available | - |
12
7) PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC) RecoveryAir PRO passed all electrical safety and EMC tests.
Electrical Safety Testing was conducted in accordance with: IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1:2012 (or IEC 60601-1:2012 reprint) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-11:2015, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home health care environment.
IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications Part 2: Lithium systems ANSI C63.27-2017 American National Standard for Evaluation of Wireless Coexistence.
EMC Testing was conducted in accordance with:
IEC / EN 60601-1-2:2014-02. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility.
Sterilization & Shelf-life Testing
RecoveryAir PRO is not sterile, therefore sterilization testing was not necessary to demonstrate the safety or performance of the device. The subject device has a shelf-life of 3 years.
Biocompatibility Testing
Cytotoxicity, Irritation and Sensitization testing was conducted to demonstrate the biocompatibility of the patient-contacting materials of RecoveryAir PRO, in accordance with ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity and ISO 10993-10:2010, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization.
Software Verification and Validation Testing
Software Verification and Validation Testing was conducted in accordance with IEC 62304:2006 Medical Device Software – Software Life Cycle Processes.
13
Animal Study
Animal testing was not required to demonstrate safety and effectiveness of RecoveryAir PRO.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the RecoveryAir PRO.
-
- CONCLUSION:
RecoveryAir PRO is substantially equivalent to the predicate device in indications for use and technological characteristics. Any differences that may exist between the subject and predicate devices do not raise questions of safety and effectiveness. Therefore, RecoveryAir PRO is as safe, as effective, and performs as well as the predicate device.
- CONCLUSION: