510(k) Report

510(k) · Cleared

Cleared

Newlife Sciences LLC, Model TMR

K070474510(k) TraditionalCleared Apr 25, 200764-day reviewClass II21 CFR 882.5890

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Newlife Sciences, LLC · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

Cleared on Apr 25, 2007 as substantially equivalent to K032928 (Mediphysics Pain Centers of America, 2003) and 6 other predicates after a 64-day review. Its family tree reaches back 3 generations to 1988. 1 later device descends from it.

Decided
Apr 25, 2007
Review
64 days
Class
Class II
Product code
GZJ
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K881114 (1988). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 2 other ancestors1990: 1 other ancestor1989: 2 other ancestors2001: 1 other ancestor1998: 1 other ancestor1996: 1 other ancestor2021: 1 descendant clearedK881114 · Empi Model 989, Tens · Empi · 1988K970203 · Epix VT · Empi · 1997K032928 · Mediphysics Pain Treatment System, Model 1 · Mediphysics Pain Centers of America · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant K032928 · Mediphysics Pain Treatment System, Model 1 · Mediphysics Pain Centers of America · 2003K970203 · Epix VT · Empi · 1997K881114 · Empi Model 989, Tens · Empi · 19880
  1. Root · 3 generations backK881114 Empi Model 989, TensEmpi · 1988
  2. 2 generations backK970203 Epix VTEmpi · 1997
  3. 1 generation backK032928 Mediphysics Pain Treatment System, Model 1Mediphysics Pain Centers of America · 2003
  4. This deviceK070474 Newlife Sciences LLC, Model TMRNewlife Sciences, LLC · 2007
  5. Descendant · cites it directly · 0 of its ownK202186 TrueRelief DeviceTruerelief · 2021

Most influential descendants

Showing 1 of 1 · See all
  • K202186TrueRelief DeviceTruerelief · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K881114Empi Model 989, TensEmpi1988—
−2K970203Epix VTEmpi1997—
−1K032928Mediphysics Pain Treatment System, Model 1Mediphysics Pain Centers of America2003—
0 (this device)K070474Newlife Sciences LLC, Model TMRNewlife Sciences, LLC2007—
+1K202186TrueRelief DeviceTruerelief2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198920
199010
199610
199810
200110
200220

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
FIG. 1 — Lineage of K070474, 1988–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GZJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GZJ device

  1. #1 K252767 actiTENS miniscore 13.1 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (7)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K032928Mediphysics Pain Treatment System, Model 1
Summary page 1
…) for pain relief. Classification Name: Class II; 21 CFR 882.5890; Product Code GZJ 3. PREDICATE DEVICES MediPhysics Pain Centers of America (K032928) Empi Epix VT TENS (K970203) Therapeutic Devices Inc. TENS (K894127) Medical Devices Matrix 1 TENS model…
Mediphysics Pain Centers of America2003—
*K970203Epix VT
Summary page 1
…tion Name: Class II; 21 CFR 882.5890; Product Code GZJ 3. PREDICATE DEVICES MediPhysics Pain Centers of America (K032928) Empi Epix VT TENS (K970203) Therapeutic Devices Inc. TENS (K894127) Medical Devices Matrix 1 TENS model 4700s (K895473) Well Life He…
Empi1997—
*K894127Lumiscope Model 1000/Apcc Model 1000
Summary page 1
…oduct Code GZJ 3. PREDICATE DEVICES MediPhysics Pain Centers of America (K032928) Empi Epix VT TENS (K970203) Therapeutic Devices Inc. TENS (K894127) Medical Devices Matrix 1 TENS model 4700s (K895473) Well Life Health Care Mini TENS WL-2403 (K020020) CE…
Lumiscope Co., Inc.1989—
*K895473DSX (TM), Digital SX, Quantum DSX, Model 4700S
Summary page 1
…Pain Centers of America (K032928) Empi Epix VT TENS (K970203) Therapeutic Devices Inc. TENS (K894127) Medical Devices Matrix 1 TENS model 4700s (K895473) Well Life Health Care Mini TENS WL-2403 (K020020) CERFAR Primo (K020803) Electro-Acuscope 85 (K88391 1)…
Medical Devices, Inc.1989—
*K020020The Izzzy-Tens (WL-2401), the Slim-Tens (WL-2402), the Mens-Tens (WL2403), the Compact…
Summary page 1
…NS (K970203) Therapeutic Devices Inc. TENS (K894127) Medical Devices Matrix 1 TENS model 4700s (K895473) Well Life Health Care Mini TENS WL-2403 (K020020) CERFAR Primo (K020803) Electro-Acuscope 85 (K88391 1) 4. DEVICE DESCRIPTION The NewLife Sciences…
Well-Life Healthcare, Inc.2002—
*K020803Cefar Medical AB Cefar Primo
Summary page 1
…c Devices Inc. TENS (K894127) Medical Devices Matrix 1 TENS model 4700s (K895473) Well Life Health Care Mini TENS WL-2403 (K020020) CERFAR Primo (K020803) Electro-Acuscope 85 (K88391 1) 4. DEVICE DESCRIPTION The NewLife Sciences LLC, Model TMR, consists of a…
Cefar Medical AB2002—
*K883911Electro-Acuscope 85
Summary page 1
…Medical Devices Matrix 1 TENS model 4700s (K895473) Well Life Health Care Mini TENS WL-2403 (K020020) CERFAR Primo (K020803) Electro-Acuscope 85 (K88391 1) 4. DEVICE DESCRIPTION The NewLife Sciences LLC, Model TMR, consists of a control console, two Treatment Probes…
Biomedical Design Instruments1990—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K202186TrueRelief DeviceTruerelief20210

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
  • None of the 11 ancestors has a recall.
  • Of its descendants, K202186 (Truerelief, 2021) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GZJ devices

GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GZJ

1in 2025

2007: 132008: 112009: 162010: 52011: 52012: 122013: 22014: 42015: 32016: 32017: 32018: 22019: 32020: 42021: 32022: 42023: 12024: 32025: 12026 (partial year): 2
2007high 16 (2009) · low 1 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GZJ

207in 2024

2007: 223 days median2008: 136 days median2009: 155 days median2010: 232 days median2011: 168 days median2012: 154 days median2014: 344 days median2015: 202 days median2016: 163 days median2017: 113 days median2019: 156 days median2020: 183 days median2021: 231 days median2022: 175 days median2024: 207 days median
2007high 344 (2014) · low 113 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GZJ

1in 2011

2007: 42008: 12011: 1
2007high 4 (2007) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GZJ

13in 2025

2007: 42008: 452009: 172010: 222011: 222012: 202013: 102014: 232015: 182016: 322017: 582018: 212019: 72020: 102021: 52022: 42023: 392024: 122025: 13
2007high 58 (2017) · low 4 (2007)2025

MAUDE reports naming product code GZJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071322344
200811136145
200916155017
20105232022
20115168122
201212154020
20132—010
20144344023
20153202018
20163163032
20173113058
20182—021
2019315607
20204183010
2021323105
2022417504
20231—039
20243207012
20251—013
20262—0—

What is it indicated for?

The NewLife Sciences LLC, Model TMR, is intended for temporary symptomatic relief of chronic intractable pain, and as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.

Indications for use as stated in the FDA summary.

Recent decisions in GZJ

The GZJ category page

  • K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc. · 2026
  • K252767actiTENS miniSublimed · 2026
  • K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC · 2025
  • K232441Unipro (K-UNIPRO-US)Tenscare, Ltd. · 2024
  • K241228TENSWaveZynex Medical Officer · 2024

https://510kreport.com/device/K070474 · printed Nov 3, 2026

Cite this page

510(k) Report. “K070474: Newlife Sciences LLC, Model TMR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070474

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026