FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
K Number: K231789
·
Decision Mar 11, 2024
Classifications
1
FEI Numbers
191
Registration Numbers
191
Same Product Code
161
Applicant Total
12
Review Days
265
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Basic Information
- Device Name
- Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII)
- K Number
- K231789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Guangzhou Xinbo Electronic Co., Ltd.
- Date Received
- June 20, 2023
- Decision Date
- March 11, 2024
- Product Code
- NGX
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | FDA class 2 | Physical Medicine |
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Other Clearances by Guangzhou Xinbo Electronic Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K230711 | Pain Therapy Device(Model: P.T.S-X) | May 16, 2024 | Substantially Equivalent |
| K231167 | Conductive Silicone Rubber Electrode | Aug 9, 2023 | Substantially Equivalent |
| K231164 | Conductive carbon film electrode | Aug 9, 2023 | Substantially Equivalent |
| K202671 | DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) | Nov 12, 2021 | Substantially Equivalent |
| K212948 | Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) | Nov 1, 2021 | Substantially Equivalent |
| K202636 | Metallic Fabric Electrodes | Aug 16, 2021 | Substantially Equivalent |
| K202638 | Pain Therapy Device | Jul 15, 2021 | Substantially Equivalent |
| K200402 | DR-HO'S Electro Therapy Conductive Gel | Nov 25, 2020 | Substantially Equivalent |
| K190118 | Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) | May 13, 2020 | Substantially Equivalent |
| K172887 | XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) | Apr 19, 2018 | Substantially Equivalent |